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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 089139

RESPORAL (DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE)
6MG;120MG
Marketing Status: Discontinued
Active Ingredient: DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE
Proprietary Name: RESPORAL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 6MG;120MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A089139
Product Number: 001
Approval Date: Jun 16, 1988
Applicant Holder Full Name: PIONEER PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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