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FOI Summary; NADA 200-066 (original); Agrimycin(TM)-343 Soluble Powder (oxytetracycline hydrochloride); July 15, 1994
--Editor's abstract


ANADA: 200-066



Agri Laboratories, Ltd.
P.O. Box 3103
St. Joseph, Missouri 64503


a. Established Name: oxytetracycline hydrochloride

b.Trade/ Proprietary Name: Agrimycin(TM)-343 Soluble Powder

c. Dosage Form: soluble powder

d. How Supplied: 4.78 oz packets, 50 packets/bucket

e. How Dispensed: OTC

f. Amount of Active Ingredient: Each packet contains 102.4 grams of OTC HCl

g. Route of Administration: Administer orally in drinking water

h. Labeled Dosage And Indications:



    Control of infectious synovitis caused by Mycoplasma synoviae
    DOSAGE: 200-400 mg/gal

    Control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli
    DOSAGE: 400-800-mg/gal

    Control of fowl cholera caused by Pasteurella multocida
    DOSAGE: 400-800-mg/gal



    Control of Hexamitiasis caused by Hexamita meleagridis
    DOSAGE: 200-400 mg/gal

    Control of infectious synovitis caused by Mycoplasma synoviae
    DOSAGE: 400 mg/gal

    Growing turkeys: Control of body weight complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis)
    DOSAGE: 25 mg/lb




    Bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis , susceptible to oxytetracycline. Bacterial pneumonia caused by Pasteurella multocida , susceptible to oxytetracycline.
    DOSAGE: 10 mg/lb body weight

    FOR BREEDING SWINE: Leptospirosis (reducing the incidence of abortions and shedding of leptospira) caused by Leptospira pomona , susceptible to oxytetracycline.
    DOSAGE: 10 mg/lb body weight



    Mix fresh solutions daily. Use as sole source of drinking water. Do not mix this product directly with milk or milk replacers. Administer one hour before or two hours after feeding milk or milk replacers. Consult a poultry diagnostic laboratory or poultry pathologist for diagnosis or advice on dosage for chickens or turkeys. As a generalization, 200 chickens will drink one gallon of water per day for each week of age. Turkeys will consume twice that amount. Administer up to 5 days to swine and 7 to 14 days for chickens and turkeys.

i. Species: Chickens, Turkeys, and Swine

j. Pioneer Product

Oxytet Soluble; oxytetracycline HCI; NADA 130-435; I.D. "Listed" Product: Russell.

k. Date of Approval: July 15, 1994


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 genetic product, Agri Laboratories Ltd. was granted a waiver from conducting an in vivo bioequivalence study for Oxytetracycline HCl Soluble Powder. The genetic and pioneer products contain the same active ingredient and are water soluble powders administered as oral solutions. The genetic product contains no inactive ingredients that may significantly affect the absorption of the active ingredient.



The tolerances established for the pioneer product apply to the generic product. Tolerances of 3 ppm in uncooked kidney and 1 ppm in uncooked muscle, liver, fat, and skin are established for residues of oxytetracycline in chickens and turkeys under 21 CFR 556.500(a). A tolerance of 0.1 ppm in uncooked edible tissues is established for residues of oxytetracycline in swine under 21 CFR 556.500(b).

Withdrawal Time

When a waiver from the requirement of an in vivo bioequivalence study is granted, the withdrawal times are those previously assigned to the pioneer product.

For oxytetracycline powder, a withdrawal period of zero has been established for chickens. A withdrawal period of 5 days is established for turkeys [21 CFR 520.1660(d)]. Oxytetracycline HCl soluble powder is not to be administered to chickens or turkeys producing eggs for human consumption. A withdrawal period of 13 days is established for swine [21 CFR 520.1660(d)].

Regulatory Method:

The analytical method for the determination of oxytetracycline in tissues uses a microbiological assay 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.


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


The following generic labeling and currently approved pioneer labeling are attached

1. Facsimile package label for generic oxytetracycline HCl-Agrimycin(TM)-343 Soluble Powder.
2. Facsimile bucket label for generic oxytetracycline HCl-Agrimycin(TM)-343 Soluble Powder.
3. Approved pioneer package label for oxytetracycline HCl-Oxytet Soluble

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