# Withdrawal of Approval of New Animal Drug Applications; Chorionic Gonadotropin; Naloxone; Oxymorphone; Oxytocin
**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) at the sponsor's request because the products are no longer manufactured or marketed.
**DATES:**
Withdrawal of approval is effective September 20, 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 sponsors in table 1 of this document have requested that FDA withdraw approval of the four NADAs listed because the products are no longer manufactured or marketed.
| NADA No. | Trade name (drug) | Applicant |
| --- | --- | --- |
| 030-525 | NUMORPHAN (oxymorphone hydrochloride) Injection | Endo Pharmaceuticals Inc., 100 Painters Dr., Chadds Ford, PA 19317. |
| 035-825 | NARCAN (naloxone hydrochloride) Injection | Endo Pharmaceuticals Inc., 100 Painters Dr., Chadds Ford, PA 19317. |
| 046-822 | VETOCIN (oxytocin) Injection | United Vaccines, A Harlan Sprague Dawley, Inc., Co., P.O. Box 4220, Madison, WI 53711. |
| 103-090 | CHORTROPIN (chorionic gonadotropin) Injection | United Vaccines, A Harlan Sprague Dawley, Inc., Co., P.O. Box 4220, Madison, WI 53711. |
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that approval of NADAs 030-525, 035-825, 046-822, and 103-090, and all supplements and amendments thereto, is hereby withdrawn, effective September 20, 2012.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 5, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.