Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 018998

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VASOTEC (ENALAPRIL MALEATE)
2.5MG
Marketing Status: Prescription

Active Ingredient: ENALAPRIL MALEATE
Proprietary Name: VASOTEC
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N018998
Product Number: 005
Approval Date: Jul 26, 1988
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

VASOTEC (ENALAPRIL MALEATE)
5MG
Marketing Status: Prescription

Active Ingredient: ENALAPRIL MALEATE
Proprietary Name: VASOTEC
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N018998
Product Number: 001
Approval Date: Dec 24, 1985
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

VASOTEC (ENALAPRIL MALEATE)
10MG
Marketing Status: Prescription

Active Ingredient: ENALAPRIL MALEATE
Proprietary Name: VASOTEC
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N018998
Product Number: 002
Approval Date: Dec 24, 1985
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

VASOTEC (ENALAPRIL MALEATE)
20MG
Marketing Status: Prescription

Active Ingredient: ENALAPRIL MALEATE
Proprietary Name: VASOTEC
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N018998
Product Number: 003
Approval Date: Dec 24, 1985
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information