Source: http://thefederalregister.com/2012/09/14/2012-22646.html
Timestamp: 2018-09-23 22:12:22
Document Index: 299965215

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

Federal Register | New Animal Drugs; Change of Sponsor; Change of Sponsor Addres
21 CFR Parts 510 and 520
SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for three abbreviated new animal drug applications (ANADAs) from Teva Animal Health, Inc., to Phibro Animal Health Corp. FDA is also amending the regulations to reflect a change of sponsor's address for Phibro Animal Health Corp. and for Eka Chemicals, Inc.
DATES: This rule is effective September 14, 2012.
FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855, 240-276-8300, Email:steven.vaughn@fda.hhs.gov.
2. In § 510.600, in the table in paragraph (c)(1), revise the entries for “Eka Chemicals, Inc.” and “Phibro Animal Health”; and in the table in paragraph (c)(2), revise the entries for “061088” and “066104” to read as follows:
Firm name and address Drug labeler code ******* Eka Chemicals, Inc., 1850 Parkway Pl. SE., suite 1200, Marietta, GA 30067 061088 ******* Phibro Animal Health Corp., GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., suite 21, Teaneck, NJ 07666 066104 *******
Drug labeler code Firm name and address ******* 061088 Eka Chemicals, Inc., 1850 Parkway Pl. SE., suite 1200, Marietta, GA 30067 ******* 066104 Phibro Animal Health Corp., GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., suite 21, Teaneck, NJ 07666 *******
§ 520.1265 [Amended]
4. In paragraph (b)(2) of § 520.1265, remove “Nos. 057561, 059130, and 061623” and in its place add “Nos. 057561, 061623, and 066104”.
§ 520.2220a [Amended]
5. In paragraph (a)(2) of § 520.2220a, remove “Nos. 000069, 054925, 057561, 058829, 059130, and 061623” and in its place add “Nos. 000069, 054925, 057561, 058829, 061623, and 066104”.
§ 520.2455 [Amended]
6. In paragraph (b)(2) of § 520.2455, remove “No. 059130” and in its place add “No. 066104”. Dated: September 6, 2012. Bernadette Dunham, Director, Center for Veterinary Medicine.