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Withdrawal of Approval of New Animal Drug Applications; Coumaphos; Novobiocin; Buquinolate and Lincomycin

---
identifier: "/us/fr/2010-10567"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Withdrawal of Approval of New Animal Drug Applications; Coumaphos; Novobiocin; Buquinolate and Lincomycin"
title_number: 0
title_name: "Federal Register"
section_number: "2010-10567"
section_name: "Withdrawal of Approval of New Animal Drug Applications; Coumaphos; Novobiocin; Buquinolate and Lincomycin"
positive_law: false
currency: "2010-05-05"
last_updated: "2010-05-05"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2010-10567"
document_type: "notice"
publication_date: "2010-05-05"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "75 FR 24719"
fr_volume: 75
docket_ids:
  - "Docket No. FDA-2010-N-0002"
effective_date: "2010-05-17"
fr_action: "Notice."
---

#  Withdrawal of Approval of New Animal Drug Applications; Coumaphos; Novobiocin; Buquinolate and Lincomycin

**AGENCY:**

Food and Drug Administration, HHS.

**ACTION:**

Notice.

**SUMMARY:**

The Food and Drug Administration (FDA) is withdrawing approval of three new animal drug applications (NADAs). In a final rule published elsewhere in this issue of the *Federal Register* , FDA is amending the animal drug regulations to remove portions reflecting approval of the single NADA of the three that is codified.

**DATES:**

Withdrawal of approval is effective May 17, 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, e-mail: *[email protected]* .

**SUPPLEMENTARY INFORMATION:**

The following sponsors have requested that FDA withdraw approval of the three NADAs listed in Table 1:

| Sponsor | NADA No./Product | 21 CFR Cite |
| --- | --- | --- |
| Pharmacia & Upjohn Co., a Division of Pfizer, Inc., 235 East 42d St., New York, NY 10017 | NADA 13-467/ALBAMIX Susceptibility Disks | Not codified |
| Pharmacia & Upjohn Co., a Division of Pfizer, Inc., 235 East 42d St., New York, NY 10017 | NADA 45-738/LINCOMIX/BONAID | Not codified |
| Purina Mills, Inc., P.O. Box 66812, St. Louis, MO 63166-6812 | NADA 42-117/Purina 6 Day Worm-Kill Concentrate | 558.185 (017800) |

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 13-467, 42-117, and 45-738, and all supplements and amendments thereto, is hereby withdrawn, effective May 17, 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 NADA 42-117.

Dated: April 30, 2010.

Bernadette Dunham,

Director, Center for Veterinary Medicine.