• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Animal & Veterinary

  • Print
  • Share
  • E-mail

ANADA 200-146 Oxytetracycline HCl Soluble Powder - supplemental approval (August 15, 1996)

Approval Date: August 15, 1996

I. GENERAL INFORMATION:
NADA200-146
Sponsor:Phoenix Scientific, Inc.
3915 South 48th St. Terrace
P.O. Box 6457
St. Joseph, Missouri 64506-0457
Generic Name:oxytetracycline hydrochloride
Trade Name:Oxytetracycline HCl Soluble Powder
Marketing Status: 
Effect of Supplement:This supplemental application provides for the addition of the 2.26 kg (5 lb) bucket with a scoop. The scoop has also been added to the 907.2 g (2 lb) bucket. Revised labeling provides the statement warning against use in calves to be processed for veal and female dairy cattle 20 months of age or older.
  1. Established Name: oxytetracycline hydrochloride
  2. Trade Name/Proprietary Name: OXYTETRACYCLINE HCl SOLUBLE POWDER
  3. Dosage Form: Soluble Powder for drinking water
  4. How Supplied: OXYTETRACYCLINE HCl SOLUBLE POWDER 50 grams is supplied in 907.2 gram (2 Lb.) buckets or 125 grams is supplied in 2.26 Kg (5 Lb.) buckets.
  5. How Dispensed: OTC
  6. Amount of Active Ingredients: Each gram contains oxytetracycline hydrochloride equivalent to 55 mg oxytetracycline hydrochloride
  7. Species: Chickens, Turkeys, Cattle, Swine, and Sheep
  8. Labeled Dosage and Indications: See indications in the attached labeling.
  9. Pioneer "Listed" Product: Terramycin® Soluble Powder, NADA 008-622
  10. Effect of Supplement: This supplemental application provides for the addition of the 2.26 kg (5 lb) bucket with a scoop. The scoop has also been added to the 907.2 g (2 lb) bucket. Revised labeling provides the statement warning against use in calves to be processed for veal and female dairy cattle 20 months of age or older.
II. TARGET ANIMAL SAFETY AND DRUG EFFECTIVENESS:

See original approval ANADA 200-146, (Federal Register, January 30, 1996, vol 61, No. 20:2914- 2915)

III. HUMAN FOOD SAFETY

See original approval ANADA 200-146, (Federal Register, January 30, 1996, vol 61, No. 20:2914- 2915)

IV. AGENCY CONCLUSIONS

This ANADA submitted under 512(b) of the Federal Food, Drug, and Cosmetic Act satisfies the requirements of section 512(n) of the act and demonstrates that Oxytetracycline HCl Soluble Powder, when used under its proposed conditions of use, is safe and effective for the labeled indications.

Attachments: The following generic labeling and currently approved pioneer labeling are attached.

  1. Generic Labels:
    • Facsimile package label for generic oxytetracycline HCl - OXYTETRACYCLINE HCl SOLUBLE POWDER (2 lb bucket)
    • Facsimile package label for generic oxytetracycline HCl - OXYTETRACYCLINE HCl SOLUBLE POWDER (5 lb bucket)
  2. Pioneer label

Copies of applicable labels may be obtained by writing to the:

Freedom of Information Office
Center for Veterinary Medicine, FDA
7500 Standish Place
Rockville, MD 20855