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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019309

VASOTEC (ENALAPRILAT)
1.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ENALAPRILAT
Proprietary Name: VASOTEC
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N019309
Product Number: 001
Approval Date: Feb 9, 1988
Applicant Holder Full Name: BIOVAIL LABORATORIES INTERNATIONAL SRL
Marketing Status:  Discontinued
Patent and Exclusivity Information
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