Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019221

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VASERETIC (ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE)
5MG;12.5MG
Marketing Status: Prescription
Active Ingredient: ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE
Proprietary Name: VASERETIC
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG;12.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019221
Product Number: 003
Approval Date: Jul 12, 1995
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
VASERETIC (ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE)
10MG;25MG
Marketing Status: Prescription
Active Ingredient: ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE
Proprietary Name: VASERETIC
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG;25MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N019221
Product Number: 001
Approval Date: Oct 31, 1986
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

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