Source: https://www.federalregister.gov/documents/2010/10/26/2010-27011/animal-drugs-feeds-and-related-products-withdrawal-of-approval-of-new-animal-drug-applications
Timestamp: 2016-09-28 23:59:21
Document Index: 52901524

Matched Legal Cases: ['§\u2009520', 'art2', '§\u2009520', '§\u2009556', 'art4', '§\u2009556', '§\u2009556', 'art5', '§\u2009556', '§\u2009556', 'art6', '§\u2009556', '§\u2009558', 'art8', '§\u2009558', '§\u2009558', 'art9', '§\u2009558', '§\u2009558', 'art10', '§\u2009558', '§\u2009558', 'art11', '§\u2009558']

:: Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications; Aklomide; Levamisole Hydrochloride; Nitromide and Sulfanitran
Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications; Aklomide; Levamisole Hydrochloride; Nitromide and Sulfanitran
A Rule by the Food and Drug Administration on 10/26/2010
This rule is effective November 5, 2010.
75 FR 65565
65565-65566
2010-27011
https://www.federalregister.gov/d/2010-27011
Fort Dodge Animal Health, a Division of Wyeth Holdings, a Wholly Owned Subsidiary of Pfizer, Inc., 235 East 42d St., New York, NY 10017 has requested that FDA withdraw approval of the eight NADAs listed in Table 1 of this document because they are no longer manufactured or marketed.
Table 1NADA No.ProductEstablished name of drug(s)NADA 11-141UNISTAT-2 Type A medicated articlenitromide and sulfanitran.NADA 14-250NOVASTAT Type A medicated articleaklomide and sulfanitran.NADA 34-536ALKOMIX Type A medicated article ALKOMIX-3 Type A medicated articleaklomide. aklomide, sulfanitran, and roxarsone.NADA 34-537NOVASTAT-3 Type A medicated articleaklomide, sulfanitran, and roxarsone.NADA 35-388NOVASTAT-W Soluble Powderaklomide and sulfanitran.NADA 39-666UNISTAT-3 Type A medicated articlenitromide, sulfanitran, and roxarsone.NADA 44-015TRAMISOL Type A medicated articlelevamisole.NADA 45-455TRAMISOL Type A medicated articlelevamisole.
In a notice published elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADA 11-141, 14-250, 34-536, 34-537, 35-388, 39-666, 44-015, and 45-455, and all supplements and amendments thereto, is withdrawn, effective November 5, 2010. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these withdrawals of approval.
§ 520.2320 [Removed]
Start Amendment Part2. Remove § 520.2320.End Amendment Part
§ 556.30 [Removed]
Start Amendment Part4. Remove § 556.30.End Amendment Part
Start Printed Page 65566
§ 556.220 [Removed]
Start Amendment Part5. Remove § 556.220.End Amendment Part
§ 556.680 [Removed]
Start Amendment Part6. Remove § 556.680.End Amendment Part
§ 558.4 [Amended]
Start Amendment Part8. In § 558.4, in paragraph (d), in the “Category I” table, remove the listing for “Aklomide”; and in the “Category II” table, remove the listings for “Levamisole”, “Nitromide” immediately followed in sequence by “Sulfanitran”, “Nitromide” immediately followed in sequence by “Sulfanitran” and by “Roxarsone”; “Sulfanitran” immediately followed in sequence by “Aklomide”, and the two listings for “Sulfanitran” immediately followed in sequence by “Aklomide” and by “Roxarsone”.End Amendment Part
§ 558.35 [Removed]
Start Amendment Part9. Remove § 558.35.End Amendment Part
§ 558.315 [Removed]
Start Amendment Part10. Remove § 558.315.End Amendment Part
§ 558.376 [Removed]
Start Amendment Part11. Remove § 558.376.End Amendment Part
[FR Doc. 2010-27011 Filed 10-25-10; 8:45 am]