# 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: *[email protected]* .
**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that approval of NADAs 65-137, 121-337, 132-923, and 138-342, and all supplements and amendments thereto, is hereby withdrawn, effective September 24, 2010.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.