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U.S. Department of Health and Human Services

Animal & Veterinary

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ANADA 200-071 Euthasol™ - original approval

Approval Date: February 24, 1994

I. GENERAL INFORMATION:

NADA200-071
Sponsor:Delmarva Laboratories, Incorporated
P.O. Box 525
Midlothian, VA 23113
Generic Name:pentobarbital sodium and phenytoin sodium
Trade Name:Euthasol™
Marketing Status:Prescription

Dosage Form: Non-sterile parenteral solution

How Supplied: Euthasol(TM) is available in 100 mL multiple dose vials.

How Dispensed: Prescription use (Rx)

Amount of Active Ingredients:

Each mL contains: 390 mg pentobarbital sodium (barbituric acid derivative) and 50 mg phenytoin sodium

Amount of Inactive Ingredients:

ethyl alcohol 10%, propylene glycol 18%, rhodamine B 0.003688 mg, benzyl alcohol (preservative) 2%, water for injection q.s. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH.

Route of Administration:

Intravenous injection is preferred. Intracardiac injection may be made when intravenous injection is impractical, as in a very small dog, or in a comatose dog with impaired vascular functions. Good injection skill is necessary for intracardiac injection. The calculated dose should be given in a single bolus injection. For intravenous injection, a needle of sufficient gauge to insure intravenous placement of the entire dose should be used.

Species: Canine

Indications for Use: For use in dogs for humane, painless, and rapid euthanasia

Labeled Dosage : 1 mL for each 10 pounds of weight.

Pioneer Product:

Beuthanasia®-D Special (390 mg pentobarbital sodium (barbituric acid derivative) and 50 mg phenytoin sodium), manufactured for Schering Corporation (NADA 119-807)

Date of Approval: February 24, 1994

2. 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