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Product Details for NDA 011265

PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE)
15MG/5ML;6.25MG/5ML
Marketing Status: Prescription
Active Ingredient: DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
Proprietary Name: PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
Dosage Form; Route of Administration: SYRUP; ORAL
Strength: 15MG/5ML;6.25MG/5ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AA
Application Number: N011265
Product Number: 002
Approval Date: Apr 2, 1984
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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