75 FR 177 pg. 55810 - Withdrawal of Approval of New Animal Drug Applications; Chloramphenicol, Lincomycin, Pyrantel Tartrate, and Tylosin Phosphate and Sulfamethazine
Type: NOTICEVolume: 75Number: 177Page: 55810
Docket number: [Docket No. FDA-2010-N-0425]
FR document: [FR Doc. 2010-22809 Filed 9-13-10; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0425]
Withdrawal of Approval of New Animal Drug Applications; Chloramphenicol, Lincomycin, Pyrantel Tartrate, and Tylosin Phosphate and Sulfamethazine
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is withdrawing approval of four new animal drug applications (NADAs). In a final rule published elsewhere in this issue of the Federal Register , FDA is amending the regulations to remove portions reflecting approval of these NADAs.
DATES:
Withdrawal of approval is effective September 24, 2010.
FOR FURTHER INFORMATION CONTACT:
John Bartkowiak, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9079, email: john.bartkowiak@fda.hhs.gov .
SUPPLEMENTARY INFORMATION:
John J. Ferrante, 11 Fairway Lane, Trumbull, CT 06611; International Nutrition, Inc., 7706 "I" Plaza, Omaha, NE 68127; and Feed Service Co., Inc., 303 Lundin Blvd., P.O. Box 698, Mankato, MN 56001 have requested that FDA withdraw approval of the four NADAs listed in table 1 because they are no longer manufactured or marketed:
| Sponsor | NADA Number Product (Established Name of Drug) | 21 CFR Cite (Sponsor's Drug Labeler Code) |
|---|---|---|
| John J. Ferrante, 11 Fairway Lane, Trumbull, CT 06611 | NADA 65-137 AMPHICOL-V Capsules (chloramphenicol) | § 520.390b (058034) |
| International Nutrition, Inc., 7706 "I" Plaza, Omaha, NE 68127 | NADA 121-337 INI Swine Ban-Wormer B-9.6 BA. (pyrantel tartrate) | § 558.485 (043733) |
| International Nutrition, Inc., 7706 "I" Plaza, Omaha, NE 68127 | NADA 132-923 LINCO 8/LINCO 20 (lincomycin) | § 558.325 (043733) |
| Feed Service Co., Inc., 303 Lundin Blvd., P.O. Box 698, Mankato, MN 56001 | NADA 138-342 TYLAN 5 Sulfa-G Premix (tylosin and sulfamethazine) | § 558.630 (030841) |
Therefore, under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, and in accordance with § 514.116 Notice of withdrawal of approval of application (21 CFR 514.116), notice is given that approval of NADAs 65-137, 121-337, 132-923, and 138-342, and all supplements and amendments thereto, is hereby withdrawn, effective September 24, 2010.
In a final rule published elsewhere in this issue of the Federal Register , FDA is amending the animal drug regulations to reflect the withdrawal of approval of these NADAs.
Dated: September 1, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-22809 Filed 9-13-10; 8:45 am]
BILLING CODE 4160-01-S