# Withdrawal of Approval of New Animal Drug Applications; Chlortetracycline; Sulfathiazole; Penicillin
**AGENCY:**
Food and Drug Administration, HHS.
**ACTION:**
Notification of withdrawal of approval.
**SUMMARY:**
The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) and two abbreviated new animal drug applications (ANADAs) for three-way, fixed-ratio combination drug Type A medicated articles containing chlortetracycline, sulfathiazole, and penicillin. This action is being taken at the sponsor's request because these products are no longer manufactured or marketed.
**DATES:**
Withdrawal of approval is effective March 31, 2014.
**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.
**SUPPLEMENTARY INFORMATION:**
Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 has requested that FDA withdraw approval of the following NADA and two ANADAs because the products are no longer manufactured or marketed:
| NADA/ANADA | Proprietary name |
| --- | --- |
| 039-077 | CSP 250 (chlortetracycline, sulfathiazole, and penicillin) Type A medicated article. |
| 200-140 | AUREOZOL (chlortetracycline, sulfathiazole, and penicillin) Type A medicated article. |
| 200-167 | AUREOZOL 500 Granular (chlortetracycline, sulfathiazole, and penicillin) Type A medicated article. |
The NADAs listed were identified as being affected by guidance for industry (GFI) #213, “New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209”, December 2013.
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that approval of NADA 039-077, ANADA 200-140, and ANADA 200-167, and all supplements and amendments thereto, is hereby withdrawn, effective March 31, 2014.
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: March 12, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.