# Withdrawal of Approval of New Animal Drug Applications; Butorphanol; Doxapram; Triamcinolone; Tylosin
**AGENCY:**
Food and Drug Administration, HHS.
**ACTION:**
Notice.
**SUMMARY:**
The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) and three abbreviated new animal drug applications (ANADAs) at the sponsors' request because the products are no longer manufactured or marketed.
**DATES:**
Withdrawal of approval is effective October 15, 2012.
**FOR FURTHER INFORMATION CONTACT:**
David Alterman, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-453-6843, email: *[email protected].*
**SUPPLEMENTARY INFORMATION:**
The following sponsors have requested that FDA withdraw approval of the NADA and ANADAs listed in table 1 of this document because the products are no longer manufactured or marketed.
| NADA/ANADA No. | Trade name (drug) | Applicant |
| --- | --- | --- |
| 100-556 | Vigorena Feeds Hy-Ty Premix (tylosin phosphate) | Springfield Milling Corp., Vigorena Feeds, Springfield, MN 56087. |
| 200-435 | RESPIRAM (doxapram hydrochloride) Injection | Modern Veterinary Therapeutics, LLC, 18001 Old Cutler Rd., Suite 317, Miami, FL 33157. |
| 200-446 | BUTORPHINE (butorphanol tartrate) Injection | Modern Veterinary Therapeutics, LLC, 18001 Old Cutler Rd., Suite 317, Miami, FL 33157. |
| 200-459 | VETAZINE (triamcinolone) Cream | Modern Veterinary Therapeutics, LLC, 18001 Old Cutler Rd., Suite 317, Miami, FL 33157. |
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of NADA 100-556 and ANADAs 200-435, 200-446, and 200-459, and all supplements and amendments thereto, is hereby withdrawn, effective October 15, 2012.
Elsewhere in this issue of the *Federal Register* , FDA is amending the animal drug regulations to reflect the voluntary withdrawal of approval of these applications.
Dated: September 27, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.