Withdrawal of Approval of New Animal Drug Applications

---
identifier: "/us/fr/2012-2109"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Withdrawal of Approval of New Animal Drug Applications"
title_number: 0
title_name: "Federal Register"
section_number: "2012-2109"
section_name: "Withdrawal of Approval of New Animal Drug Applications"
positive_law: false
currency: "2012-02-01"
last_updated: "2012-02-01"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2012-2109"
document_type: "notice"
publication_date: "2012-02-01"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "77 FR 5028"
fr_volume: 77
docket_ids:
  - "Docket No. FDA-2011-N-0003"
effective_date: "2012-02-13"
fr_action: "Notice."
---


#  Withdrawal of Approval of New Animal Drug Applications

**AGENCY:**

Food and Drug Administration, HHS.

**ACTION:**

Notice.

**SUMMARY:**

The Food and Drug Administration (FDA) is withdrawing approval of 20 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 February 13, 2012.

**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:**

The following sponsors have requested that FDA withdraw approval of the 20 NADAs listed in table 1 of this document because the products are no longer manufactured or marketed:

| Application No. | Trade name | Applicant |
| --- | --- | --- |
| NADA 014-485 | METOPHANE Inhalation (methoxyflurane) | Medical Developments, International Ltd., 556 Morris Ave., Summit, NJ 07901-1330. |
| NADA 032-322 | LIQUISONE F with Cerumene (hexamethyltetracosane, prednisolone,  tetracaine, neomycin sulfate) | Evsco Pharmaceuticals,  an Affiliate of IGI, Inc.,  Box 209, Harding Hwy., Buena, NJ 08310. |
| NADA 044-655 | NEOMYCANE Ophthalmic Ointment (neomycin sulfate) | Evsco Pharmaceuticals,  an Affiliate of IGI, Inc.,  Box 209, Harding Hwy., Buena, NJ 08310. |
| NADA 045-288 | OPTISONE (neomycin sulfate, prednisolone acetate) | Evsco Pharmaceuticals,  an Affiliate of IGI, Inc.,  Box 209, Harding Hwy., Buena, NJ 08310. |
| NADA 049-890 | NORCO T-2 Pre-Pak (tylosin phosphate) | Norco Mills of Norfolk, Inc., P.O. Box 56, Norfolk, NE 68701. |
| NADA 055-034 | CHLORASOL (chloramphenicol) | Evsco Pharmaceuticals,  an Affiliate of IGI, Inc.,  Box 209, Harding Hwy., Buena, NJ 08310. |
| NADA 055-052 | Chlora-Tabs 100 (chloramphenicol) | Evsco Pharmaceuticals,  an Affiliate of IGI, Inc.,  Box 209, Harding Hwy., Buena, NJ 08310. |
| NADA 065-158 | CHLORICOL (chloramphenicol) | Evsco Pharmaceuticals,  An Affiliate of IGI, Inc.,  Box 209, Harding Hwy., Buena, NJ 08310. |
| NADA 065-259 | CHLORASONE Ophthalmic Ointment (chloramphenicol, prednisolone acetate) | Evsco Pharmaceuticals,  an Affiliate of IGI, Inc.,  Box 209, Harding Hwy., Buena, NJ 08310. |
| NADA 065-488 | BENZA-PEN (penicillin G benzathine,  penicillin G procaine) | Walco International, Inc.,  15 West Putnam, Porterville, CA 93257. |
| NADA 095-953 | MOORMABOOST TY 4000 Medicated (tylosin phosphate) | ADM Alliance Nutrition, Inc.,  1000 North 30th St.,  Quincy, IL 62305-3115. |
| NADA 100-689 | DIFIL Syrup (diethylcarbamazine citrate) | Evsco Pharmaceuticals,  an Affiliate of IGI, Inc.,  Box 209, Harding Hwy., Buena, NJ 08310. |
| NADA 100-690 | DIFIL Tablets  (diethylcarbamazine citrate) | Evsco Pharmaceuticals,  an Affiliate of IGI, Inc.,  Box 209, Harding Hwy., Buena, NJ 08310. |
| NADA 107-957 | TYLAN 20 Sulfa-G (tylosin phosphate and sulfamethazine) | ADM Alliance Nutrition, Inc.,  1000 North 30th St.,  Quincy, IL 62305-3115. |
| NADA 111-069 | TYLAN 40 Sulfa-G (tylosin phosphate and sulfamethazine) | ADM Alliance Nutrition, Inc.,  1000 North 30th St.,  Quincy, IL 62305-3115. |
| NADA 131-956 | TYLAN Sulfa-G (tylosin phosphate and sulfamethazine) | ADM Alliance Nutrition, Inc.,  1000 North 30th St.,  Quincy, IL 62305-3115. |
| NADA 131-957 | TYLAN 40 (tylosin phosphate) | ADM Alliance Nutrition, Inc.,  1000 North 30th St.,  Quincy, IL 62305-3115. |
| NADA 133-490 | Ban-D-Wormer II BANMINTH (pyrantel tartrate) | ADM Alliance Nutrition, Inc.,  1000 North 30th St.,  Quincy, IL 62305-3115. |
| NADA 140-842 | HYGROMIX 2.4 Premix (hygromycin B) | ADM Alliance Nutrition, Inc.,  1000 North 30th St.,  Quincy, IL 62305-3115. |
| NADA 140-958 | EQUIPHEN Paste (phenylbutazone) | Luitpold Pharmaceuticals, Inc., Animal Health Division,  Shirley, NY 11967. |

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 014-485, 032-322, 044-655, 045-288, 049-890, 055-034, 055-052, 065-158, 065-259, 065-488, 095-953, 100-689, 100-690, 107-957, 111-069, 131-956, 131-957, 133-490, 140-842, and 140-958, and all supplements and amendments thereto, is hereby withdrawn, effective February 13, 2012.

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 applications.

Dated: January 26, 2012.

Bernadette Dunham,

Director, Center for Veterinary Medicine.