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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 088864

PROMETHAZINE W/ DEXTROMETHORPHAN (DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE)
15MG/5ML;6.25MG/5ML
Marketing Status: Prescription
Active Ingredient: DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
Proprietary Name: PROMETHAZINE W/ DEXTROMETHORPHAN
Dosage Form; Route of Administration: SYRUP; ORAL
Strength: 15MG/5ML;6.25MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A088864
Product Number: 001
Approval Date: Jan 4, 1985
Applicant Holder Full Name: WOCKHARDT BIO AG
Marketing Status:  Prescription
Patent and Exclusivity Information
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