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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 088811

BROMFED-DM (BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE)
2MG/5ML;10MG/5ML;30MG/5ML
Marketing Status: Prescription
Active Ingredient: BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Proprietary Name: BROMFED-DM
Dosage Form; Route of Administration: SYRUP; ORAL
Strength: 2MG/5ML;10MG/5ML;30MG/5ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AA
Application Number: A088811
Product Number: 001
Approval Date: Jun 7, 1985
Applicant Holder Full Name: WOCKHARDT BIO AG
Marketing Status:  Prescription
Patent and Exclusivity Information
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