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U.S. Department of Health and Human Services

Animal & Veterinary

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Abbreviated New Animal Drug Approvals - May/June 2004

FDA Veterinarian Newsletter May/June 2004 Volume XIX, No 3

Company
Generic and (Brand) Names
Indications
Routes/Remarks

Vetoquinol N.-A., Inc.
(ANADA 200-307)
Penicillin G Potassium
Turkeys. The treatment of erysipelas caused by Erysipelothrix rhusiopathiae.
ORAL—The ANADA provides for the use of penicillin G in the drinking water of turkeys for the treatment of erysipelas caused by Erysipelothrix rhusiopathiae. Vetoquinol N.-A., Inc.’s Penicillin G Potassium, USP, is approved as a generic copy of Fort Dodge Animal Health’s Penicillin G Potassium, USP, approved under NADA 055-060.
Federal Register 03/03/04

Phoenix Scientific, Inc.
(ANADA 200-345)
Lincomycin hydrochloride monohydrate/Spectinomycin dihydrochloride pentahydrate (Lincomycin and Spectinomycin Soluble Powder)
Chickens. For administration to chickens up to seven days of age as an aid in the control of airsacculitis caused by either Mycoplasma synoviae or Mycoplasma gallisepticum susceptible to lincomycin-spectinomycin and complicated chronic respiratory disease (air sac infection) caused by Escherichia coli and M. gallisepticum susceptible to lincomycin-spectinomycin.
ORAL—The ANADA provides for oral use of lincomycin and spectinomycin soluble powder to make medicated drinking water for administration to chickens up to seven days of age as an aid in the control of several bacterial respiratory diseases. Phoenix Scientific’s Lincomycin-Spectinomycin Water Soluble Powder is approved as a generic copy of Pharmacia & Upjohn’s L-S 50 (lincomycin hydrochloride monohydrate/ spectinomycin sulfate tetrahydrate) Water Soluble Powder, approved under NADA 046-109.
Federal Register 03/22/04