Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 088814

PROMETHAZINE W/ CODEINE (CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE)
10MG/5ML;6.25MG/5ML
Marketing Status: Discontinued
Active Ingredient: CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
Proprietary Name: PROMETHAZINE W/ CODEINE
Dosage Form; Route of Administration: SYRUP; ORAL
Strength: 10MG/5ML;6.25MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A088814
Product Number: 001
Approval Date: Nov 22, 1985
Applicant Holder Full Name: HR CENCI LABORATORIES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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