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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 009319

AMBENYL (BROMODIPHENHYDRAMINE HYDROCHLORIDE; CODEINE PHOSPHATE)
12.5MG/5ML;10MG/5ML
Marketing Status: Discontinued
Active Ingredient: BROMODIPHENHYDRAMINE HYDROCHLORIDE; CODEINE PHOSPHATE
Proprietary Name: AMBENYL
Dosage Form; Route of Administration: SYRUP; ORAL
Strength: 12.5MG/5ML;10MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N009319
Product Number: 006
Approval Date: Jan 10, 1984
Applicant Holder Full Name: FOREST LABORATORIES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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