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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020507

TECZEM (DILTIAZEM MALATE; ENALAPRIL MALEATE)
EQ 180MG HYDROCHLORIDE;5MG
Marketing Status: Discontinued
Active Ingredient: DILTIAZEM MALATE; ENALAPRIL MALEATE
Proprietary Name: TECZEM
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 180MG HYDROCHLORIDE;5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020507
Product Number: 001
Approval Date: Oct 4, 1996
Applicant Holder Full Name: BIOVAIL LABORATORIES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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