Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 013483

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DISOPHROL (DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE)
6MG;120MG
Marketing Status: Discontinued

Active Ingredient: DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE
Proprietary Name: DISOPHROL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 6MG;120MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N013483
Product Number: 004
Approval Date: Sep 13, 1982
Applicant Holder Full Name: SCHERING PLOUGH HEALTHCARE PRODUCTS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

DRIXORAL (DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE)
6MG;120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE
Proprietary Name: DRIXORAL
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 6MG;120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N013483
Product Number: 003
Approval Date: Sep 13, 1982
Applicant Holder Full Name: SCHERING PLOUGH HEALTHCARE PRODUCTS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information