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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 202940

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (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: BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
Dosage Form; Route of Administration: SYRUP; ORAL
Strength: 2MG/5ML;10MG/5ML;30MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A202940
Product Number: 001
Approval Date: Jul 21, 2014
Applicant Holder Full Name: PHARMACEUTICAL ASSOCIATES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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