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New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications 

---
identifier: "/us/fr/2015-31040"
source: "fr"
legal_status: "authoritative_unofficial"
title: "New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications"
title_number: 0
title_name: "Federal Register"
section_number: "2015-31040"
section_name: "New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications"
positive_law: false
currency: "2015-12-09"
last_updated: "2015-12-09"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2015-31040"
document_type: "rule"
publication_date: "2015-12-09"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
cfr_references:
  - "21 CFR Part 520"
  - "21 CFR Part 558"
fr_citation: "80 FR 76387"
fr_volume: 80
docket_ids:
  - "Docket No. FDA-2015-N-0002"
effective_date: "2015-12-21"
fr_action: "Notification of withdrawal."
---

#  New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications

**AGENCY:**

Food and Drug Administration, HHS.

**ACTION:**

Notification of withdrawal.

**SUMMARY:**

The Food and Drug Administration (FDA) is withdrawing approval of two new animal drug applications (NADAs) and two abbreviated new animal drug applications (ANADAs). This action is being taken at the sponsors' requests because these products are no longer manufactured or marketed.

**DATES:**

Withdrawal of approval is effective December 21, 2015.

**FOR FURTHER INFORMATION CONTACT:**

Sujaya Dessai, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5761, *[email protected].*

**SUPPLEMENTARY INFORMATION:**

The following three sponsors have requested that FDA withdraw approval of the NADAs and ANADAs listed in the following table because the products are no longer manufactured or marketed:

| File No. | Sponsor | Product name | 21 CFR |
| --- | --- | --- | --- |
| 140-680 | Pharmgate LLC, 1015 Ashes Dr., suite 102, Wilmington, NC 28405 | TYLAN (tylosin phosphate) Premix | 558.625 |
| 140-681 | Pharmgate LLC, 1015 Ashes Dr., suite 102, Wilmington, NC 28405 | TYLAN SULFA G (tylosin phosphate and sulfamethazine) Premix | 558.630 |
| 200-028 | Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514 | EVICT 300 (pyrantel pamoate) Suspension | 520.2043 |
| 200-383 | Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201 | CLINDAROBE (clindamycin) Capsules | 520.446 |

Therefore, under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, and in accordance with 21 CFR 514.116 *Notice of withdrawal of approval of application,* notice is given that approval of NADA 140-680, NADA 140-681, ANADA 200-028, and ANADA 200-383, and all supplements and amendments thereto, is hereby withdrawn, effective December 21, 2015.

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:  December 4, 2015.

Bernadette Dunham,

Director, Center for Veterinary Medicine.