Source: https://www.law.cornell.edu/cfr/text/21/522.1662a
Timestamp: 2018-05-27 05:35:56
Document Index: 348163777

Matched Legal Cases: ['art 522', '§ 522', '§ 510', '§ 510', '§ 510', '§ 510', '§ 510', '§ 510', '§ 510', '§ 522', 'art 522', 'arts 510', 'arts 510', 'arts 510', 'arts 510', 'arts 510', 'arts 510', 'arts 510', 'arts 520', 'arts 510', 'arts 510', 'arts 510', 'arts 510', 'arts 520', 'arts 520', 'arts 510', 'arts 510', 'arts 510', 'arts 510', 'arts 510', 'arts 522', 'arts 510', 'arts 510', 'arts 510', 'arts 510', 'arts 500', 'arts 510', 'arts 520']

21 CFR 522.1662a - Oxytetracycline hydrochloride injection. | US Law | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter E › Part 522 › Section 522.1662a
21 CFR 522.1662a - Oxytetracycline hydrochloride injection.
§ 522.1662a Oxytetracycline hydrochloride injection.
(1)Specifications. The drug contains 50 milligrams of oxytetracycline hydrochloride in each milliliter of sterile solution.
(2)Sponsor. See No. 054628 in § 510.600(c) of this chapter.
(3)Conditions of use.
(i) The drug is intended for use in beef cattle, beef calves, nonlactating dairy cattle, and dairy calves for treatment of disease conditions caused by one or more of the following oxytetracycline sensitive pathogens listed as follows: pneumonia and shipping fever complex (Pasteurella spp.; Hemophilis spp.; Klebsiella spp. ), bacterial enteritis (scours) (E. coli), foot-rot (Spherophorus necrophorus), diphtheria (Spherophorus necrophorus), wooden tongue (Actinobacillus lignieresi), leptospirosis (Leptospira pomona), and wound infections; acute metritis; traumatic injury (caused by a variety of bacterial organisms (such as streptococcal and staphylococcal organisms).)
(ii) It is administered by intramuscular injection of 3 to 5 milligrams of oxytetracycline hydrochloride per pound of body weight per day. Leptospirosis, severe foot-rot and severe forms of the indicated diseases should be treated with 5 milligrams per pound of body weight per day. Treatment should be continued for 24 to 48 hours following remission of disease symptoms; however, not to exceed a total of 4 consecutive days. Only 2 milliliters of the drug should be injected per site in case of calves weighing 100 pounds or less and not more than 10 milliliters should be injected per site in adult cattle.
(iii) Discontinue treatment with the drug at least 20 days prior to slaughter of the animal. When administered to animals within 30 days of slaughter, muscle discoloration may necessitate trimming of injection site and surrounding tissues.
(iv) For use only in beef cattle, beef calves, nonlactating dairy cattle, and dairy calves.
(1)Specifications. Each milliliter of sterile solution contains 50 or 100 milligrams of oxytetracycline (as oxytetracycline hydrochloride).
(2)Sponsor. See 054628 in § 510.600(c) of this chapter.
(3)Conditions of use -
(i)Beef cattle and nonlactating dairy cattle -
(a)Amount. Three to 5 milligrams of oxytetracycline per pound of body weight per day; 5 milligrams per pound of body weight per day for the treatment of anaplasmosis, severe foot-rot, and severe cases of other indicated diseases.
(b) Indications for use. Treatment of diseases due to oxytetracycline-susceptible organisms as follows: Pneumonia and shipping fever complex associated with Pasteurella spp., Haemophilus spp., and Klebsiella spp., foot-rot and diphtheria caused by Spherophorus necrophorus, bacterial enteritis (scours) caused by Escherichia coli, wooden tongue caused by Actinobacillus lignieresi, leptospirosis caused by Leptospira pomona, and wound infections and acute metritis caused by Staphylococcus spp. and Streptococcus spp. If labeled for use by or on the order of a licensed veterinarian, it may be used for the treatment of anaplasmosis caused by Anaplasma marginale.
(c)Limitations. For 50-milligram-per-milliliter solution, administer intramuscularly or intravenously; for 100-milligram-per-milliliter solution, administer intramuscularly only. Treatment of all diseases should be instituted early and continue for 24 to 48 hours beyond remission of disease symptoms, but not to exceed a total of 4 consecutive days. Consult your veterinarian if no improvement is noted within 48 hours. Do not inject more than 10 milliliters per site in adult cattle, reducing the volume according to age and body size to 0.5 to 2 milliliters in small calves. Exceeding the highest recommended dose of 5 milligrams per pound of body weight, administering at recommended levels for more than 4 consecutive days, and/or exceeding 10 milliliters intramuscularly per injection site may result in antibiotic residues beyond the withdrawal time. Discontinue treatment at least 18 days prior to slaughter. Not for use in lactating dairy cattle.
(ii)Swine -
(a)Amount. Three to 5 milligrams of oxytetracycline per pound of body weight per day. Sows: 3 milligrams of oxytetracycline per pound of body weight, approximately 8 hours before farrowing or immediately after completion of farrowing.
(b)Indications for use. For treatment of bacterial enteritis (scours, colibacillosis) caused by Escherichia coli, pneumonia caused by Pasteurella multocida, and leptospirosis caused by Leptospira pomona. Sows: as an aid in control of infectious enteritis (baby pig scours, colibacillosis) in suckling pigs caused by Escherichia coli.
(c)Limitations. Administer intramuscularly. Do not inject more than 5 milliliters per site. Do not use for more than 4 consecutive days. Discontinue treatment at least 26 days before slaughter.
(1)Specifications. The drug contains 50 or 100 milligrams of oxytetracycline hydrochloride in each milliliter of sterile solution.
(2)Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(i) The drug is intended for use in the treatment of disease due to oxytetracycline-susceptible organisms in beef cattle and non-lactating dairy cattle. It is indicated in the treatment of pneumonia and shipping fever complex associated with Pasteurella spp., Haemophilus spp., Klebsiella spp., foot-rot and diphtheria caused by Spherophorus necrophorus, bacterial enteritis (scours) caused by Escherichia coli, wooden tongue caused by Actinobacillus lignieresi, acute metritis, and wound infections caused by staphylococcal and streptococcal organisms.
(ii) It is administered to cattle at a dosage level of 3 to 5 milligrams per pound of body weight per day. It may be administered intramuscularly or intravenously from a 50 milligram per milliliter solution. It is administered intravenously from a 100 milligram per milliliter solution. Severe foot-rot and the severe forms of the indicated diseases should be treated with 5 milligrams per pound of body weight. Treatment should be continued 24 to 48 hours following remission of disease symptoms, however, not to exceed a total of 4 consecutive days. If no improvement is noted within 24 hours, consult a veterinarian. When injecting the drug intramuscularly, do not inject more than 10 milliliters per site in adult cattle. Reduce the amount injected at each site according to the size of the animal. For very small calves do not use more than 2 milliliters per injection site.
(iii) Not for use in lactating dairy cattle. Discontinue treatment at least 19 days prior to slaughter. When administered intramuscularly within 30 days of slaughter, muscle discoloration may necessitate trimming of the injection site and surrounding tissues.
(i) In beef cattle and nonlactating dairy cattle as follows:
(a) It is used for the treatment of pneumonia and shipping fever complex associated with Pasteurella spp. and Haemophilus spp.; foot-rot and diphtheria caused by Spherophorus necrophorus; bacterial enteritis (scours) caused by Escherichia coli; wooden tongue caused by Actinobacillus lignieresi; leptospirosis caused by Leptospira pomona; wound infections and acute metritis caused by staphylococcal and streptococcal organisms.
(b) Administer by intravenous or intramuscular injection at 3 to 5 milligrams of oxytetracycline per pound of body weight per day. In the treatment of severe foot-rot and severe forms of the indicated diseases, a dosage level of 5 milligrams per pound of body weight per day is recommended.
(c) If the labeling of the drug bears the statement “Federal law restricts this drug to use by or on the order of a licensed veterinarian,” it may include additional directions for use in beef cattle and nonlactating dairy cattle for the treatment of anaplasmosis caused by Anaplasma marginale, and anthrax caused by Bacillus anthracis in which case the drug is given at 3 to 5 milligrams of oxytetracycline per pound of body weight per day for anthrax, and at 5 milligrams per pound of body weight per day for anaplasmosis.
(ii) In swine as follows:
(a) It is used for the treatment of bacterial enteritis (scours, colibacillosis) caused by Escherichia coli; pneumonia caused by Pasteurella multocida; and leptospirosis caused by Leptospira pomona. Administered to sows as an aid in the control of infectious enteritis (baby pig scours, colibacillosis) in suckling pigs caused by Escherichia coli.
(b) Administer by intramuscular injection at 3 to 5 milligrams of oxytetracycline per pound of body weight per day to swine. Administered to sows at 3 milligrams of oxytetracycline per pound of body weight approximately 8 hours before farrowing or immediately after farrowing.
(iii) In poultry (broilers, turkeys, and breeding chickens) as follows:
(a) It is used for the treatment of air sacculitis (air-sac disease, chronic respiratory disease) caused by Mycoplasma gallisepticum and Escherichia coli; fowl cholera caused by Pasteurella multocida; infectious sinusitis caused by Mycoplasma gallisepticum; and infectious synovitis caused by Mycoplasma synoviae.
(b) Administered subcutaneously to chickens 1 day to 2 weeks of age at 6.25 milligrams of oxytetracycline per bird per day diluted with 1 part of the drug to 3 parts of sterile water; to chickens 2 to 4 weeks of age using the same diluted product at 12.5 milligrams of oxytetracycline per bird; to chickens 4 to 8 weeks of age without dilution at 25 milligrams of oxytetracycline per bird; to chickens 8 weeks of age (broilers and light pullets) at 50 milligrams of oxytetracycline per bird; to adult chickens at 100 milligrams of oxytetracycline per bird.
(c) Administered subcutaneously to turkeys 1 day to 2 weeks of age and 2 to 4 weeks of age at the same dosage as chickens; to turkeys 4 to 6 weeks of age at 50 milligrams of oxytetracycline as the undiluted product per bird; to turkeys 6 to 9 weeks of age at 100 milligrams of oxytetracycline per bird; to turkeys 9 to 12 weeks of age at 150 milligrams of oxytetracycline per bird; to turkeys 12 weeks of age and older at 200 milligrams of oxytetracycline per bird. In light turkey breeds, no more than 25 milligrams per pound of body weight is administered. For the treatment of infectious sinusitis in turkeys, 1/4 to 1/2 milliliter of the drug is injected directly into each swollen sinus depending upon the age of the bird and the severity of the condition. At the time that the sinuses are treated, the drug should also be administered subcutaneously to the birds according to the dosage schedule given in paragraph (d)(3)(iii)(c) of this section. If refilling of the sinuses occurs, the treatment may be repeated in 5 to 7 days.
(iv) Treatment of all diseases should be instituted early. Treatment should continue for 24 to 48 hours beyond the remission of disease symptoms, but not exceed a total of 4 consecutive days. If no improvement is noted within 24 to 48 hours, diagnosis and therapy should be reevaluated.
(v) When injecting intramuscularly in adult livestock, do not inject more than 10 milliliters at any one site. The volume administered per injection site should be reduced according to age and body size so that 1 or 2 milliliters are injected in smaller animals such as small calves and young pigs. Intravenous administration is recommended in cattle when daily dosage exceeds 50 milliliters.
(vi) Treatment must be discontinued at least 5 days prior to slaughter for chickens and turkeys and at least 22 days prior to slaughter for cattle and swine. When administered intramuscularly to animals within 30 days of slaughter, muscle discoloration may necessitate trimming of the injection site(s) and surrounding tissues during the dressing procedure.
(vii) Not for use in lactating dairy animals. Do not administer to laying hens unless the eggs are used for hatching only.
(1)Specifications. Each milliliter of solution contains 100 milligrams of oxytetracycline hydrochloride.
(a)Amount. 3 to 5 milligrams of oxytetracycline per pound of body weight per day; 5 milligrams per pound of body weight per day for treatment of anaplasmosis, severe foot-rot, and severe cases of other indicated diseases.
(b)Indications for use. Treatment of diseases due to oxytetracycline-susceptible organisms as follows: Pneumonia and shipping fever complex associated with Pasteurella spp. and Haemophilus spp., foot-rot and diphtheria caused by Fusobacterium necrophorum, bacterial enteritis (scours) caused by Escherichia coli, wooden tongue caused by Actinobacillus lignieresii, leptospirosis caused by Leptospira pomona, and wound infections and acute metritis caused by Staphylococcus spp. and Streptococcus spp. If labeled for use by or on the order of a licensed veterinarian, it may be used for the treatment of anaplasmosis caused by Anaplasma marginale and anthrax caused by Bacillus anthracis.
(c)Limitations. Administer intramuscularly. Treatment of all diseases should be instituted early and continue for 24 to 48 hours beyond remission of disease symptoms, but not to exceed a total of 4 consecutive days. Consult your veterinarian if no improvement is noted within 48 hours. Do not inject more than 10 milliliters per site in adult cattle, reducing the volume according to age and body size to 1 to 2 milliliters in small calves. Exceeding the highest recommended dose of 5 milligrams per pound of body weight per day, administering more than the recommended number of treatments, and/or exceeding 10 milliliters intramuscularly or subcutaneously per injection site in adult beef and dairy cattle may result in antibiotic residues beyond the withdrawal period. Discontinue treatment at least 15 days prior to slaughter. Not for use in lactating dairy cattle.
(a)Amount. 3 to 5 milligrams of oxytetracycline per pound of body weight per day. Sows: 3 milligrams of oxytetracycline per pound of body weight, administered once, approximately 8 hours before farrowing or immediately after completion of farrowing.
(b)Indications for use. For treatment of bacterial enteritis (scours, colibacillosis) caused by Escherichia coli, pneumonia caused by Pasteurella multocida, and leptospirosis caused by Leptospira pomona. Sows: as an aid in control of infections enteritis (baby pig scours, colibacillosis) in suckling pigs caused by Escherichia coli.
(c)Limitations. Administer intramuscularly. Do not inject more than 5 milliliters per site in adult swine, reducing the volume according to age and body size to 1 to 2 milliliters in young pigs. Discontinue treatment at least 22 days prior to slaughter.
(1)Specifications. Each milliliter of sterile solution contains 100 milligrams of oxytetracycline as oxytetracycline hydrochloride.
(3)Conditions of use. The drug is used for the treatment of diseases due to oxytetracycline-susceptible organisms as follows:
(i)Beef cattle, beef calves, nonlactating dairy cattle, and dairy calves -
(a)Amount. 3 to 5 milligrams of oxytetracycline per pound of body weight per day.
(b) Indications for use. For the treatment of pneumonia and shipping fever complex associated with Pasteurella spp., Haemophilus spp., or Klebsiella spp.
(c)Limitations. Administer by intramuscular, intravenous, or subcutaneous injection. In severe forms of the indicated diseases, administer 5 milligrams of oxytetracycline per pound of body weight per day. Continue treatment 24 to 48 hours following remission of disease symptoms, not to exceed a total of 4 consecutive days. If no improvement is noted within 48 hours, consult a veterinarian. Do not inject more than 10 milliliters per injection site intramuscularly in adult cattle; no more than 1 milliliter per site in calves weighing 100 pounds or less. Do not slaughter cattle for 13 days after intramuscular or intravenous treatment, or 2 days after subcutaneous treatment. Exceeding the highest recommended dosage or duration of treatment (not more than 4 consecutive days) may result in residues beyond the withdrawal period. A withdrawal period has not been established for use of this product in preruminating calves. Do not use in calves to be processed for veal.
(a)Amount. 3 to 5 milligrams of oxytetracycline per pound of body weight per day. Sows: Administer once 3 milligrams of oxytetracycline per pound of body weight, approximately 8 hours before farrowing or immediately after completion of farrowing.
(c)Limitations. Administer intramuscularly. If no improvement is noted within 24 hours, consult a veterinarian. Do not inject more than 5 milliliters per site. Discontinue treatment at least 20 days prior to slaughter.
(1)Specifications. Each milliliter of sterile solution contains 50 or 100 milligrams of oxytetracycline hydrochloride.
(2)Sponsors. See No. 054628 in § 510.600(c) of this chapter for use of 50 and 100 milligrams per milliliter solution; and Nos. 016592 and 055529 in § 510.600(c) for use of 100 milligrams per milliliter solution.
(i)Amount. The drug is used in beef cattle, beef calves, nonlactating dairy cattle, and dairy calves as follows: 3 to 5 milligrams of oxytetracycline hydrochloride per pound of body weight per day; 5 milligrams per pound of body weight per day for treatment of severe forms of the indicated diseases.
(ii)Indications for use. The drug is used for treatment of bacterial pneumonia and shipping fever complex associated with Pasteurella spp.; foot-rot and calf diphtheria caused by Spherophorus necrophorus; bacterial enterities (scours) caused by Escherichia coli; wooden tongue caused by Actinobacillus lignieresi; wound infections, acute metrities, and traumatic injury caused by staphylococcal and streptococcal organisms.
(iii)Limitations. Administer 50-milligram-per-milliliter solution intramuscularly; administer 100-milligram-per-milliliter solution intravenously. Continue treatment 24 to 48 hours following remission of disease symptoms, not to exceed a total of 4 consecutive days. If no improvement is noted within 24 to 48 hours, consult a veterinarian for diagnosis and therapy. When injecting the drug intramuscularly, do no inject more than 10 milliliters per site in adult cattle. Reduce the volume administered per injection site according to age and body size. In calves weighing 100 pounds or less, do no inject more than 2 milliliters intramuscularly per site. Discontinue treatment at least 22 days before slaughter. Not for use in lactating dairy animals.
(1)Specifications. Each milliliter of sterile solution contains 50 milligrams of oxytetracycline hydrochloride.
(2)Sponsor. See No. 016592 in § 510.600(c) of this chapter.
(i)Amount. The drug is used in beef cattle, beef calves, nonlactating dairy cattle, and dairy calves as follows: Administer 3 to 5 milligrams of the oxytetracycline hydrochloride intramuscularly per pound of body weight per day.
(ii)Indications for use. The drug is used for treatment of bacterial pneumonia and shipping fever complex associated with Pasteurella spp.; foot-rot and diptheria caused by Spherophorus necrophorus; bacterial enteritis (scours) caused by Escherichia coli; wooden tongue caused by Actinobacillus lignieresi; wound infections and acute metritis caused by staphylococcal and streptococcal organisms susceptible to oxytetracycline.
(iii)Limitations. In severe forms of the indicated diseases, administer the equivalent of 5 milligrams of oxytetracycline hydrochloride per pound of body weight per day. Continue treatment 24 to 48 hours following remission of disease symptoms, not to exceed a total of 4 consecutive days. If no improvement is noted within 24 to 48 hours, consult a veterinarian for diagnosis and therapy. In adult livestock, do not inject more than 10 milliliters at any one site. Reduce the volume administered per injection site according to age and body size. In calves weighing 100 pounds or less inject only 2 milliliters per site. Discontinue treatment at least 18 days before slaughter. Not for use in lactating dairy cattle.
(1)Specifications. Each milliliter of sterile solution contains either 50 or 100 milligrams of oxytetracycline hydrochloride.
(2)Sponsor. See No. 061623 in § 510.600(c) of this chapter.
(3)Conditions of use in beef cattle and nonlactating dairy cattle -
(i)Amount. 3 to 5 milligrams per pound of body weight daily, 5 milligrams per pound for anaplasmosis, severe foot rot, and severe forms of other diseases.
(ii)Indications for use. Treatment of diseases due to oxytetracycline-susceptible organisms as follows: pneumonia and shipping fever complex associated with Pasteurella spp. and Haemophilus spp.; foot rot and diphtheria caused by Fusobacterium necrophorum; bacterial enteritis (scours) caused by Escherichia coli; wooden tongue caused by Actinobacillus lignieresii; leptospirosis caused by Leptospira pomona; acute metritis and wound infections caused by staphylococcal and streptococcal organisms; if labeled for use by or on the order of a licensed veterinarian, it may be used for treatment of anaplasmosis caused by Anaplasma marginale and anthrax caused by Bacillus anthracis.
(iii)Limitations. Administer by intravenous injection. Treatment should be continued 24 to 48 hours following remission of disease symptoms, but not to exceed a total of 4 consecutive days. If no improvement occurs within 24 to 48 hours, reevaluate diagnosis and therapy. Discontinue use at least 19 days prior to slaughter. Not for use in lactating dairy cattle.
[ 40 FR 13858, Mar. 27, 1975]
For Federal Register citations affecting § 522.1662a, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 522 after this date.
2018-04-05; vol. 83 # 66 - Thursday, April 5, 2018
83 FR 14584 - New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor&apos;s Name and Address
FR Doc. 2018-06961
Docket No. FDA-2017-N-0002
This rule is effective April 5, 2018.
21 CFR Parts 510, 520, 522, 526, and 558
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during October, November, and December 2017. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications and a change of a sponsor&apos;s name and address.
2018-03-30; vol. 83 # 62 - Friday, March 30, 2018
83 FR 13632 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor&apos;s Name and Address
FR Doc. 2018-06358
This rule is effective March 30, 2018, except for amendatory instructions 3 to 21 CFR 510.600, 9 to 21 CFR 522.300, 10 to 21 CFR 522.540, and 11 to 21 CFR 522.1081, which are effective April 9, 2018.
21 CFR Parts 510, 520, 522, 524, 556, and 558
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July, August, and September 2017. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect the withdrawal of approval of applications, changes of sponsorship of applications, and a change of a sponsor&apos;s name and address, and to make technical amendments to improve the accuracy of the regulations.
83 FR 13637 - New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications
FR Doc. 2018-06357
Notification of withdrawal.
Withdrawal of approval is effective April 9, 2018.
The Food and Drug Administration (FDA) is withdrawing approval of three new animal drug applications (NADAs). This action is being taken at the sponsors&apos; request because these products are no longer manufactured or marketed.
82 FR 58554 - New Animal Drugs; Approval of New Animal Drug Applications
FR Doc. 2017-26753
This rule is effective December 13, 2017.
21 CFR Parts 510, 520, 522, 524, 529, and 558
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for a new animal drug application (NADA) and abbreviated new animal drug applications (ANADAs) during May and June 2017. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to make technical amendments to improve the accuracy of the regulations.
2017-09-18; vol. 82 # 179 - Monday, September 18, 2017
82 FR 43482 - New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor&apos;s Address
FR Doc. 2017-19602
This rule is effective September 18, 2017.
21 CFR Parts 510, 520, 522, 524, and 558
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for a new animal drug application (NADA) and abbreviated new animal drug applications (ANADAs) during March and April 2017. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of a sponsor&apos;s address and to make technical amendments to improve the accuracy of the regulations.
82 FR 21688 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship
FR Doc. 2017-09364
This rule is effective May 10, 2017, except for amendatory instruction 3 to 21 CFR 510.600, and amendatory instruction 10 to 21 CFR 522.1002, which are effective May 22, 2017.
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January and February 2017. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect several changes of sponsorship of applications and to make correcting amendments to improve the accuracy of the regulations.
82 FR 21694 - New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application
FR Doc. 2017-09365
Withdrawal of approval is effective May 22, 2017.
The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA). This action is being taken at the sponsors&apos; request because these products are no longer manufactured or marketed.
2017-03-01; vol. 82 # 39 - Wednesday, March 1, 2017
82 FR 12167 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor&apos;s Name
FR Doc. 2017-03930
Docket No. FDA-2016-N-0002
This rule is effective March 1, 2017, except for amendments 2.a and 2.c to 21 CFR 510.600, and the amendments to 21 CFR 522.313c and 529.1186, which are effective March 13, 2017.
21 CFR Parts 510, 516, 520, 522, 529, and 558
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during November and December 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect the change of sponsorship of an application and a change of a sponsor&apos;s name.
82 FR 12170 - New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application
FR Doc. 2017-03931
Withdrawal of approval is effective March 13, 2017.
21 CFR Parts 510, 522, and 529
The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) and an abbreviated new animal drug application (ANADA) at the sponsors&apos; requests because the products are no longer manufactured or marketed.
2017-02-24; vol. 82 # 36 - Friday, February 24, 2017
82 FR 11506 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor&apos;s Address
FR Doc. 2017-03677
This rule is effective February 24, 2017, except for the amendment to 21 CFR 524.1465, which is effective March 6, 2017.
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September and October 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of several applications and a change of a sponsor&apos;s address.
81 FR 67149 - New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor&apos;s Address
FR Doc. 2016-23230
This rule is effective September 30, 2016.
The Food and Drug Administration (FDA, we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July and August 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of a sponsor&apos;s address.
81 FR 59131 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of Sponsor&apos;s Name and Address; Change of Sponsor&apos;s Address
FR Doc. 2016-19914
This rule is effective August 29, 2016, except for the amendments to 21 CFR 558.274, 58.355, 58.363, 58.550, 558.625, and 558.630, which are effective September 8, 2016.
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during May and June 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications, changes of sponsors&apos; names and addresses, and the voluntary withdrawals of approval of applications.
81 FR 48700 - New Animal Drugs; Change of Sponsor
FR Doc. 2016-17501
81 FR 36787 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship
FR Doc. 2016-13517
This rule is effective June 8, 2016 except for the amendments to 21 CFR 520.1696b, 520.2325a, 520.2261a, 558.248, and 558.625, which are effective June 20, 2016.
21 CFR Parts 510, 520, 522, 556, and 558
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during March and April 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications and the voluntary withdrawals of approval of applications that occurred in January and February.
2016-04-18; vol. 81 # 74 - Monday, April 18, 2016
81 FR 22520 - New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
FR Doc. 2016-08827
This rule is effective April 18, 2016.
21 CFR Parts 520, 522, 524, 529, 556, and 558
The Food and Drug Administration (FDA, we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January and February 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications that occurred in January and February.
81 FR - New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
FR Doc. C1-2016-07135
21 CFR Parts 510, 520, 522, 524, 528, 529, 556, and 558
81 FR 17604 - New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
FR Doc. 2016-07135
This rule is effective March 30, 2016.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during November and December 2015. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications that occurred in November and December 2015.
2015-12-09; vol. 80 # 236 - Wednesday, December 9, 2015
80 FR 76384 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawals of Approval of New Animal Drug Applications; Changes of Sponsorship
FR Doc. 2015-31042
This rule is effective December 9, 2015, except for the amendments to 21 CFR 520.446, 520.2043, 558.625, and 558.630, which are effective December 21, 2015.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September and October 2015. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications and the voluntary withdrawals of approval of applications that occurred in September and October 2015.
80 FR 61293 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor&apos;s Address
FR Doc. 2015-25918
This rule is effective October 13, 2015, except for the amendment to 21 CFR 558.460, which is effective October 23, 2015.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July and August 2015. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsor, a change of sponsor&apos;s address, a revised food safety warning, the voluntary withdrawal of approval of an NADA, and a technical amendment. This technical amendment is being made to improve the accuracy of the regulations.
80 FR 34276 - New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
FR Doc. 2015-14734
This rule is effective June 16, 2015.
21 CFR Parts 510, 520, 522, 526, and 528
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during March and April 2015. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect several nonsubstantive changes. These technical amendments are being made to improve the accuracy of the regulations.
80 FR 18773 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor&apos;s Name; Change of Sponsor&apos;s Address
FR Doc. 2015-08025
This rule is effective April 8, 2015, except for the amendment to 21 CFR 522.1004, which is effective April 20, 2015.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January and February 2015. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect several non-substantive changes. These technical amendments are being made to improve the accuracy of the regulations.
80 FR 18777 - Implantation or Injectable Dosage Form New Animal Drugs; Withdrawal of Approval of New Animal Drug Application; Fomepizole
FR Doc. 2015-08024
Withdrawal of approval is effective April 20, 2015.
The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) for a fomepizole injectable solution used as an antidote for ethylene glycol poisoning in dogs. This action is being taken at the sponsor&apos;s request because this product is no longer manufactured or marketed.
79 FR 74018 - New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor; Withdrawal of Approval of New Animal Drug Applications
FR Doc. 2014-29249
This rule is effective December 15, 2014, except for the amendment to 21 CFR 520.1660d, which is effective December 26, 2014.
21 CFR Parts 510, 520, 522, and 558
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September and October 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship of six NADAs and four ANADAs, the voluntary withdrawal of approval of an ANADA, and a correcting amendment.
79 FR 64114 - New Animal Drugs; Alfaxalone; Dinoprost; Ivermectin and Clorsulon; Nitrofurazone; Trenbolone and Estradiol Benzoate; Trimethoprim and Sulfadiazine; Tylosin; Change of Sponsor
FR Doc. 2014-25588
This rule is effective October 28, 2014.
21 CFR Parts 510, 520, 522, 524, and 556
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during August 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship of two NADAs and one ANADA, and to reflect a revised food safety warning.
79 FR 53134 - New Animal Drugs; Buprenorphine; Carprofen; Danofloxacin; Follicle Stimulating Hormone; Ractopamine; Salinomycin; Tylosin
FR Doc. 2014-20325
This rule is effective September 8, 2014.
21 CFR Parts 520, 522, and 558
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to add a cross reference to a tolerance.
79 FR 44277 - New Animal Drugs; Bacitracin Methylene Disalicylate; Dinoprost Solution; Gonadorelin Hydrochloride; Progesterone Intravaginal Inserts; Salinomycin; Ractopamine; Tylosin
FR Doc. 2014-17912
This rule is effective July 31, 2014.
21 CFR Parts 520, 522, 529, and 558
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during June 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to remove a cross-reference to a combination drug medicated feed that is no longer codified.
FR Doc. 2014-15276
This rule is effective July 2, 2014.
21 CFR Parts 510, 520, 522, 529, 556, and 558
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April and May 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to remove an obsolete entry for a drug for which approval was withdrawn in 1996.
79 FR 21126 - New Animal Drugs; Ceftiofur Sodium; Gentamicin; Xylazine
FR Doc. 2014-08445
This rule is effective April 15, 2014.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during March 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship for an ANADA.
79 FR 18156 - New Animal Drugs; Amprolium; Bambermycins; Ceftiofur; Deslorelin; Florfenicol; Florfenicol and Flunixin; Paclitaxel; Phenylbutazone; Pimobendan; Salinomycin; Tilmicosin; Tiludronate; Change of Sponsor
FR Doc. 2014-07220
This rule is effective April 1, 2014.
21 CFR Parts 510, 516, 520, 522, 526, and 558
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January and February 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect previous approval of revised food safety warnings. This is being done to improve the accuracy of the regulations. The animal drug regulations are also being amended to reflect a change of sponsorship of an NADA and a change to a sponsor&apos;s address.
79 FR 16180 - Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor
FR Doc. 2014-06131
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 104 approved new animal drug applications (NADAs) and 5 approved abbreviated new animal drug applications (ANADAs) for implantation or injectable dosage form new animal drug products from Pfizer, Inc., including its several subsidiaries and divisions, to Zoetis, Inc. FDA is also amending the animal drug regulations to remove entries describing conditions of use for new animal drug products for which no NADA is approved, to make minor corrections, and to reflect a current format. This is being done to increase the accuracy and readability of the regulations.
79 FR 10963 - New Animal Drugs; Bambermycins; Clopidol; Ivermectin; Penicillin G Procaine and Dihydrostreptomycin Sulfate; Progesterone; Robenicoxib; Sulfadimethoxine; Change of Sponsor; Change of Sponsor&apos;s Address
FR Doc. 2014-01959
This rule is effective February 27, 2014.
21 CFR Parts 510, 520, 522, 526, 529, and 558
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during December 2013. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship of an NADA and a change to a sponsor&apos;s address.
2013-12-09; vol. 78 # 236 - Monday, December 9, 2013
78 FR 73697 - New Animal Drugs; Hyaluronate Sodium; Hydrogen Peroxide; Imidacloprid and Moxidectin; Change of Sponsor
FR Doc. 2013-29234
This rule is effective December 9, 2013.
21 CFR Parts 510, 522, 524, and 529
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during October 2013. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship of an ANADA.
78 FR 66263 - New Animal Drugs; Afoxolaner; Carprofen; Ceftiofur Hydrochloride; Monensin
FR Doc. 2013-26473
This rule is effective November 5, 2013.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September 2013. FDA is also informing the public of the availability of summaries on the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship for an ANADA.
2013-10-25; vol. 78 # 207 - Friday, October 25, 2013
78 FR 63870 - New Animal Drugs; Change of Sponsor; Gonadorelin; Ivermectin; Ractopamine; Trimethoprim and Sulfadiazine Suspension; Tulathromycin
FR Doc. 2013-25172
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July 2013. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship for an ANADA.
78 FR 44432 - New Animal Drugs; Change of Sponsor; Fentanyl; Iron Injection
FR Doc. 2013-17754
This rule is effective July 24, 2013.
21 CFR Parts 510, 522, and 524
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for two approved new animal drug applications (NADAs) from Alstoe, Ltd., Animal Health, to Sogeval S.A., and a change of sponsor for an NADA from Nexcyon Pharmaceuticals, Inc. to Elanco Animal Health, A Division of Eli Lilly & Co.
78 FR 33698 - New Animal Drugs; Dexmedetomidine; Lasalocid; Melengestrol; Monensin; and Tylosin; Correction
FR Doc. 2013-13331
This rule is effective June 5, 2013.
The Food and Drug Administration (FDA) is correcting a document amending the animal drug regulations to reflect approval actions for new animal drug applications and abbreviated new animal drug applications during March 2013 that appeared in the Federal Register of April 30, 2013. FDA is correcting the approved strengths of dexmedetomidine hydrochloride injectable solution. This correction is being made to improve the accuracy of the animal drug regulations.
78 FR 25182 - New Animal Drugs; Dexmedetomidine; Lasalocid; Melengestrol; Monensin; and Tylosin
FR Doc. 2013-10152
This rule is effective April 30, 2013.
21 CFR Parts 522 and 558
2013-04-09; vol. 78 # 68 - Tuesday, April 9, 2013
78 FR 21058 - New Animal Drugs; Change of Sponsor
FR Doc. 2013-07542
This rule is effective April 9, 2013.
21 CFR Parts 510, 520, 522, 524, 526, 529, and 558
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 43 approved new animal drug applications (NADAs) and 3 approved abbreviated new animal drug applications (ANADAs) from Boehringer Ingelheim Vetmedica, Inc. to Strategic Veterinary Pharmaceuticals, Inc.
78 FR 19986 - New Animal Drugs; Enrofloxacin; Tilmicosin; Tylosin
FR Doc. 2013-07571
This rule is effective April 3, 2013.
21 CFR Parts 510, 522, and 558
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications and abbreviated new animal drug applications during February 2013. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable.
2013-03-25; vol. 78 # 57 - Monday, March 25, 2013
78 FR 17866 - New Animal Drug Approvals; Change of Sponsor; Change of Sponsor&apos;s Drug Labeler Code; Gonadorelin Acetate; Isoflurane; Praziquantel; Propofol; Sevoflurane; Triamcinolone Acetonide
FR Doc. 2013-06748
This rule is effective March 25, 2013.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January 2013. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship for an NADA and ANADA, and a change of a sponsor&apos;s drug labeler code.
78 FR 17595 - New Animal Drugs; Changes of Sponsor
FR Doc. 2013-06126
This rule is effective March 22, 2013.
78 FR 14667 - New Animal Drug Applications; Alfaprostol; Bicyclohexylammonium Fumagillin; N -Butyl Chloride; Competitive Exclusion Culture; Dichlorophene and Toluene; Flurogestone Acetate; Isoflurane; Pyrantel; Tylosin; Tylosin and Sulfamethazine
FR Doc. 2013-04999
Docket No. FDA-2012-N-1167
This rule is effective March 18, 2013.
21 CFR Parts 510, 520, 522, 529, and 558
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal approval of 19 new animal drug applications (NADAs) and one abbreviated new animal drug application (ANADA). The applications are being withdrawn for lack of compliance with the reporting requirements in an FDA regulation.
78 FR 5713 - New Animal Drugs; Cefpodoxime; Meloxicam
FR Doc. 2013-01647
This rule is effective January 28, 2013.
21 CFR Parts 510, 520, and 522
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during December 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
77 FR 76862 - New Animal Drugs; Enrofloxacin; Melengestrol; Meloxicam; Pradofloxacin; Tylosin
FR Doc. 2012-31397
This rule is effective December 31, 2012.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during November 2012. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable.
77 FR 72254 - New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food
FR Doc. 2012-29322
RIN 0910-AG17
Docket No. FDA-2012-N-1067
Submit either electronic or written comments by March 5, 2013. See section VI of this document for the proposed effective date of a final rule based on this proposed rule.
21 CFR Parts 500, 520, 522, 524, 529, 556, and 558
The Food and Drug Administration (FDA) is proposing to revise the animal drug regulations regarding tolerances for residues of approved and conditionally approved new animal drugs in food by standardizing, simplifying, and clarifying the determination standards and codification style. In addition, we are proposing to add definitions for key terms. The purpose of the revision is to enhance understanding of tolerance determination and improve the readability of the regulations.
77 FR 64715 - New Animal Drugs; Approvals; Changes of Sponsor; Change of Sponsor&apos;s Name; Change of Sponsor&apos;s Address; Alfaxalone; Ivermectin and Clorsulon; Narasin; Triptorelin
FR Doc. 2012-25989
This rule is effective October 23, 2012.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September 2012. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship for four ophthalmic ointments, a change of sponsor&apos;s name, and a change of sponsor&apos;s address.
77 FR 60301 - New Animal Drugs; Butorphanol; Doxapram; Triamcinolone; Tylosin
FR Doc. 2012-24331
21 CFR Parts 510, 522, 524, and 558
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal approval of a new animal drug application (NADA) and three abbreviated new animal drug applications (ANADAs) at the sponsors&apos; request because the products are no longer manufactured or marketed.
2012-09-10; vol. 77 # 175 - Monday, September 10, 2012
77 FR 55413 - New Animal Drugs; Chorionic Gonadotropin; Naloxone; Oxymorphone; Oxytocin
FR Doc. 2012-22196
Docket No. FDA-2012-N-0902
This rule is effective September 20, 2012.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of four new animal drug applications (NADAs) at the sponsor&apos;s request because the products are no longer manufactured or marketed.
77 FR 55414 - New Animal Drugs; Enrofloxacin; Tylvalosin
FR Doc. 2012-22194
This rule is effective September 10, 2012.
21 CFR Parts 520, 522, and 556
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
77 FR 46612 - New Animal Drugs; Change of Sponsor; Change of Sponsor Address; Azaperone; Miconazole, Polymyxin B, and Prednisolone Suspension
FR Doc. 2012-19147
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for two new animal drug applications (NADAs) from Janssen Pharmaceutica NV, to Elanco Animal Health, a Division of Eli Lilly & Co. FDA is also amending the animal drug regulations to reflect a change of sponsor&apos;s address for Veterinary Service, Inc.
21 CFR 522.1662a — Oxytetracycline Hydrochloride Injection.