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U.S. Department of Health and Human Services

Animal & Veterinary

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ANADA 200-049 TETRACYCLINE HYDROCHLORIDE SOLUBLE POWDER-324 - original approval

Approval Date: September 30, 1993

I. GENERAL INFORMATION:

NADA200-049
Sponsor:Agri Laboratories, Ltd.
P.O. Box 3103
St. Joseph, MO 64503
Generic Name:tetracycline hydrochloride
Trade Name:TETRACYCLINE HYDROCHLORIDE SOLUBLE POWDER-324
Marketing Status: 
  1. ANADA: 200-049
  2. Sponsor:
    Agri Laboratories, Ltd.
    P.O. Box 3103
    St. Joseph, MO 64503
  3. Trade Name: TETRACYCLINE HYDROCHLORIDE SOLUBLE POWDER-324
  4. EstablishedName: tetracycline hydrochloride
  5. Dosage Form: soluble powder
  6. How Supplied:

    (Eds. note: The following table consists of 4 columns.)

     Product SizePacket LabelCannister (Tub) LabelBucket (Pail) Label
     1.26 oz. Yes No Yes, 50 x 1.26 oz.3-1/2 gal. pail 
     2.52 oz. Yes No Yes, 50 x 2.52 oz., 5. gal. pail
     5.0 oz. Yes No Yes, 50 x 5.0 oz., 6 gal. pail 
     2 lb. No Yes* 4x2 lb. Carton Label** 
     5 lb. No  No Yes, 1 qal. pail 

    * The container for this is the 70 oz. cannister.

    ** The container for this is a corrugated carton.

  7. How Dispensed: OTC
  8. Amount of Active Ingredient: Each pound of the product contains 324 grams of tetracycline hydrochloride.
  9. Route of Administration: Oral- in the drinking water (calves, swine, chickens, and turkeys) or as a drench or by dose syringe (calves).
  10. Species: chickens and turkeys, swine and calves.
  11. Labeled Dosage:
    calves and swine: 10 mg/lb of body weight, daily for 3 to 5 days.
    chickens and turkeys at a level of 25 mg/lb of body weight daily for 7 to 14 days.
  12. Indications for Use:

    Claims: For use in the control and treatment of the following conditions in swine, calves and poultry.

    SWINE:

    • Bacterial enteritis (scours) caused by Escherichia coli and bacterial pneumonia associated with Pasteurella spp., Hemophilus spp. and Klebsiella spp. susceptible to tetracycline.
    • Bacterial enteritis (scours) caused by Escherichia coli and bacterial pneumonia (shipping fever complex) associated with Pasteurella spp., Hemophilus spp. and Klebsiella spp. susceptible to tetracycline.

    CHICKENS:

    • Control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli ; infectious synovitis caused by Mycoplasma synoviae susceptible to tetracycline.

    TURKEYS:

    • Control of infectious synovitis caused by Mycoplasma synoviae and bluecomb (transmissible enteritis, corona viral enteritis) caused by complicating bacterial organisms susceptible to tetracycline.
  13. Pioneer Product: Tetracycline (tetracycline hydrochloride) Soluble Powder-324, NADA 065-496, Fermenta Animal Health.
  14. Date of Approval: September 30, 1993

II. TARGET ANIMAL SAFETY AND DRUG EFFECTIVENESS:

Under the provisions of the Federal Food, Drug, and Cosmetic Act, as amended by the Generic Animal Drug and Patent Term Restoration Act, (53 FR 50460, December 15, 1988, First GADPTRA Policy Letter) an abbreviated new animal drug application (ANADA) may be submitted for a generic version of an approved new animal drug (pioneer product). New target animal safety data, drug effectiveness data, and human food safety data (other than tissue residue data) are not required for approval of an ANADA. An ANADA relies on the target animal safety, drug effectiveness, and human food safety data in the pioneer's new animal drug application. Ordinarily, the ANADA sponsor shows that the generic product is bioequivalent to the pioneer. If bioequivalence is demonstrated through a clinical end-point study, then a tissue residue study to establish the withdrawal time for the generic product is also required. For certain dosage forms, the agency will grant a waiver from conducting an in vivo bioequivalence study (55 FR 24645, June 18, 1990; Fifth GADPTRA Policy Letter; Bioequivalence Guideline, April 1990).

Based upon the formulation characteristics of the generic product, Agri Laboratories. Ltd. was granted a waiver from conducting an in vivo bioequivalence study for tetracycline hydrochloride soluble powder. The generic and pioneer products are soluble powders with the same active and inactive ingredients. The generic and pioneer products also contain the same concentration of active ingredient.

III. HUMAN FOOD SAFETY:

Tolerance for the marker residue
The tolerance for the pioneer product applies to the generic product.

A tolerance of 0.25 ppm (negligible residue) is established for tetracycline residues in the uncooked edible tissues of calves, swine, chickens and turkeys under 21 CFR 556.720.

Withdrawal times
When a waiver of the in vivo bioequivalence study is granted, the generic product withdrawal times are those previously assigned to the pioneer product (21 CFR 520. 2345d).

Withdrawal Times: 4 days in swine, chickens and turkeys; 5 days in cattle

Regulatory Method
The analytical method for the determination of tetracycline in tissues uses a microbiological procedure. This method is found in the Antibiotic Residues in Milk, Dairy Products, and Animal Tissues: Methods, Reports and Protocols, revised October 1968, National Center for Antibiotic and Insulin Analysis, FDA, Washington, D.C. 20204.

IV. AGENCY CONCLUSIONS:

This ANADA satisfies the requirements of section 512 of the Act and demonstrates that tetracycline hydrochloride, when used under its proposed conditions of use, is safe and effective for its labeled indications.

V. ATTACHMENTS:

The following final generic labeling and currently approved pioneer packet labeling are attached.

Generic:

  • packet and bucket - 1.26 oz., 2.52 oz. and 5.0 oz.
  • tub - 2 lb., 5 lb., and a carton (4 X 2 lb. tub )

Pioneer:

  • packet- 5.0 oz.

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

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