Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 018708

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DORAL (QUAZEPAM)
15MG
Marketing Status: Prescription

Active Ingredient: QUAZEPAM
Proprietary Name: DORAL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 15MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N018708
Product Number: 001
Approval Date: Dec 27, 1985
Applicant Holder Full Name: GALT PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

DORAL (QUAZEPAM)
7.5MG
Marketing Status: Discontinued

Active Ingredient: QUAZEPAM
Proprietary Name: DORAL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 7.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N018708
Product Number: 003
Approval Date: Feb 26, 1987
Applicant Holder Full Name: GALT PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information