Source: https://www.law.cornell.edu/cfr/text/21/522.2424
Timestamp: 2017-05-28 12:31:16
Document Index: 34222626

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

21 CFR 522.2424 - Thiamylal. | US Law | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter E › Part 522 › Section 522.2424 21 CFR 522.2424 - Thiamylal.
§ 522.2424 Thiamylal.
(a)Specifications. The drug is a sterile powder. It is reconstituted with sterile distilled water, water for injection, or sodium chloride injection, to a desired concentration of 0.5 to 4 percent sodium thiamylal.
(b)Sponsors. See Nos. 054628 and 054771 in § 510.600(c) of this chapter.
(c)Conditions of use - (1)Amount. Administer by intravenous injection to effect. The average single dose is:
(i)Dogs and cats: 8 milligrams (mg) per pound of body weight (when used with a preanesthetic, generally one-half the normal dose).
(ii)Swine: 40 mg per 5 pounds (lbs) of body weight.
(iii)Horses: Light anesthesia, 1 gram per 500 lbs to 1,100 lbs of body weight; deep anethesia, 1 gram per 300 lbs of body weight (40 mg/12 lbs of body weight).
(iv)Cattle: Short duration, 20 mg/5 lbs of body weight; longer duration, 40 mg/7 lbs of body weight.
(2)Indications for use. It is used as an ultra-short-acting anesthetic in dogs, cats, swine, horses, and cattle.
(3)Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[ 79 FR 16196, Mar. 25, 2014]
Title 21 published on 10-May-2017 03:43The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 522 after this date.2017-05-10; vol. 82 # 89 - Wednesday, May 10, 201782 FR 21688 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship
typeregulations.gov FR Doc.2017-09364 RIN Docket No.FDA-2017-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; correcting amendments. 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. 21 CFR Parts 510, 520, 522, 524, and 558 SummaryThe 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.
typeregulations.gov FR Doc.2017-09365 RIN Docket No.FDA-2017-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification of withdrawal. Withdrawal of approval is effective May 22, 2017. 21 CFR Part 522 SummaryThe 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, 201782 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
typeregulations.gov FR Doc.2017-03930 RIN Docket No.FDA-2016-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. 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 SummaryThe 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.
typeregulations.gov FR Doc.2017-03931 RIN Docket No.FDA-2017-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification of withdrawal. Withdrawal of approval is effective March 13, 2017. 21 CFR Parts 510, 522, and 529 SummaryThe 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, 201782 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
typeregulations.gov FR Doc.2017-03677 RIN Docket No.FDA-2016-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This rule is effective February 24, 2017, except for the amendment to 21 CFR 524.1465, which is effective March 6, 2017. 21 CFR Parts 510, 520, 522, 524, and 558 SummaryThe 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.
2016-09-30; vol. 81 # 190 - Friday, September 30, 201681 FR 67149 - New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor&apos;s Address
2015-06-16; vol. 80 # 115 - Tuesday, June 16, 201580 FR 34276 - New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
typeregulations.gov FR Doc.2015-14734 RIN Docket No.FDA-2015-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendments. This rule is effective June 16, 2015. 21 CFR Parts 510, 520, 522, 526, and 528 SummaryThe 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.
2015-04-08; vol. 80 # 67 - Wednesday, April 8, 201580 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
typeregulations.gov FR Doc.2015-08024 RIN Docket No.FDA-2015-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification of withdrawal. Withdrawal of approval is effective April 20, 2015. 21 CFR Part 522 SummaryThe 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.
2014-12-15; vol. 79 # 240 - Monday, December 15, 201479 FR 74018 - New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor; Withdrawal of Approval of New Animal Drug Applications
typeregulations.gov FR Doc.2014-29249 RIN Docket No.FDA-2014-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule, technical amendment. 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 SummaryThe 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.
2014-09-08; vol. 79 # 173 - Monday, September 8, 201479 FR 53134 - New Animal Drugs; Buprenorphine; Carprofen; Danofloxacin; Follicle Stimulating Hormone; Ractopamine; Salinomycin; Tylosin
2013-03-25; vol. 78 # 57 - Monday, March 25, 201378 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
typeregulations.gov FR Doc.2013-06748 RIN Docket No.FDA-2013-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective March 25, 2013. 21 CFR Parts 510, 522, 524, and 529 SummaryThe 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.
2013-01-28; vol. 78 # 18 - Monday, January 28, 201378 FR 5713 - New Animal Drugs; Cefpodoxime; Meloxicam
typeregulations.gov FR Doc.2013-01647 RIN Docket No.FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This rule is effective January 28, 2013. 21 CFR Parts 510, 520, and 522 SummaryThe 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.
2012-09-10; vol. 77 # 175 - Monday, September 10, 201277 FR 55413 - New Animal Drugs; Chorionic Gonadotropin; Naloxone; Oxymorphone; Oxytocin
typeregulations.gov FR Doc.2012-22196 RIN Docket No.FDA-2012-N-0902 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective September 20, 2012. 21 CFR Parts 510 and 522 SummaryThe 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.
2012-08-06; vol. 77 # 151 - Monday, August 6, 201277 FR 46612 - New Animal Drugs; Change of Sponsor; Change of Sponsor Address; Azaperone; Miconazole, Polymyxin B, and Prednisolone Suspension
typeregulations.gov FR Doc.2012-19147 RIN Docket No.FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective August 6, 2012. 21 CFR Parts 510, 522, and 524 SummaryThe 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.
2012-05-07; vol. 77 # 88 - Monday, May 7, 201277 FR 26697 - New Animal Drugs; Change of Sponsor; Change of Sponsor Address; Change of Sponsor Name and Address; Fomepizole
typeregulations.gov FR Doc.2012-10892 RIN Docket No.FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 7, 2012. 21 CFR Parts 510 and 522 SummaryThe Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor name from Bioniche Teoranta to Mylan Institutional, LLC; a change of sponsor for fomepizole injectable solution from Synerx Pharma, LLC, to Mylan Institutional, LLC; and a change of sponsor address for Modern Veterinary Therapeutics, LLC.