Notice of Approval of New Animal Drug Applications; Chlortetracycline

---
identifier: "/us/fr/03-17440"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Notice of Approval of New Animal Drug Applications; Chlortetracycline"
title_number: 0
title_name: "Federal Register"
section_number: "03-17440"
section_name: "Notice of Approval of New Animal Drug Applications; Chlortetracycline"
positive_law: false
currency: "2003-07-10"
last_updated: "2003-07-10"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "03-17440"
document_type: "notice"
publication_date: "2003-07-10"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "68 FR 41161"
fr_volume: 68
fr_action: "Notice."
---


#  Notice of Approval of New Animal Drug Applications; Chlortetracycline

**AGENCY:**

Food and Drug Administration, HHS.

**ACTION:**

Notice.

**SUMMARY:**

The Food and Drug Administration (FDA) is providing notice that in 2001 it approved a supplemental new animal drug application (NADA) filed by Alpharma, Inc. The supplemental NADA provided for use of chlortetracycline Type A medicated articles to make Type B and Type C medicated swine feeds for the control of porcine proliferative enteropathies (ileitis). The applicable section of the regulation did not require amendment.

**FOR FURTHER INFORMATION CONTACT:**

Joan C. Gotthardt, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: *[email protected]* .

**SUPPLEMENTARY INFORMATION:**

In accordance with section 512(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(i)) and 21 CFR 514.105(a) and 514.106(a), FDA is providing notice that in 2001 it approved a supplemental NADA that was not the subject of a final rule. A final rule was not published because 21 CFR 558.128 did not require amendment.

On November 15, 2001, FDA approved a supplement filed by Alpharma, Inc., One Executive Dr., P.O. Box 1399, Fort Lee, NJ 07024 to NADA 48-761 for AUREOMYCIN (chlortetracycline) Type A medicated articles. The supplemental NADA provided for use of AUREOMYCIN Type A medicated articles to make Type B and Type C medicated swine feeds for the control of porcine proliferative enteropathies (ileitis) caused by *Lawsonia intracellularis* susceptible to chlortetracycline. No new data were submitted. The necessary amendment to 21 CFR 558.128 was made in a final rule (65 FR 45881, July 26, 2000) for the 2000 supplemental approval of the identical claim for Alpharma, Inc.'s CHLORMAX (chlortetracycline) Type A medicated articles, approved under NADA 046-699.

A freedom of information summary containing approved product labeling may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

Dated:  June 25, 2003.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.