Source: https://www.federalregister.gov/documents/2012/05/14/2012-11382/oral-dosage-form-new-animal-drugs-change-of-sponsor-griseofulvin-powder-levamisole-hydrochloride
Timestamp: 2017-11-18 06:33:58
Document Index: 265664740

Matched Legal Cases: ['art 520', 'art 520', '§\u2009520', '§\u2009520', '§\u2009520', '§\u2009520', '§\u2009520']

Federal Register :: Oral Dosage Form New Animal Drugs; Change of Sponsor; Griseofulvin Powder; Levamisole Hydrochloride Powder; Oxytetracycline Powder
Oral Dosage Form New Animal Drugs; Change of Sponsor; Griseofulvin Powder; Levamisole Hydrochloride Powder; Oxytetracycline Powder
A Rule by the Food and Drug Administration on 05/14/2012
This rule is effective May 14, 2012.
https://www.federalregister.gov/d/2012-11382 https://www.federalregister.gov/d/2012-11382
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for five abbreviated new animal drug applications (ANADAs) for griseofulvin powder, levamisole hydrochloride soluble powder, and oxytetracycline hydrochloride soluble powder from Teva Animal Health, Inc., to Cross Vetpharm Group, Ltd.
Teva Animal Health, Inc., 3915 South 48th St. Ter., St. Joseph, MO 64503, has informed FDA that it has transferred ownership of, and all rights and interest in, ANADA 200-391 for Griseofulvin Powder, ANADAs 200-146 and 200-247 for Oxytetracycline Hydrochloride Soluble Powder, and ANADAs 200-313 and 200-386 for Levamisole Hydrochloride Soluble Pig Wormer and Drench Powder to Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland. Accordingly, the agency is amending the regulations in part 520 (21 CFR part 520) to reflect the transfer of ownership and a current format.
2. In paragraph (b)(2) of § 520.1100, remove “059130” and in its place add “061623”.
3. In § 520.1242, revise the section heading to read as follows:
§ 520.1242
4. In § 520.1242a, revise the section heading to read as set forth below, and in paragraph (b)(4) remove “059130” and in its place add “061623”.
Levamisole powder.
5. In § 520.1660d, in paragraphs (b)(5), (d)(1)(ii)(A)(
[FR Doc. 2012-11382 Filed 5-11-12; 8:45 am]