Product Details for ANDA 213273
ENALAPRIL MALEATE (ENALAPRIL MALEATE)
2.5MG
Marketing Status: Prescription
5MG
Marketing Status: Prescription
10MG
Marketing Status: Prescription
20MG
Marketing Status: Prescription
2.5MG
Marketing Status: Prescription
Active Ingredient: ENALAPRIL MALEATE
Proprietary Name: ENALAPRIL MALEATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213273
Product Number: 001
Approval Date: Jul 7, 2022
Applicant Holder Full Name: PRINSTON PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
ENALAPRIL MALEATE (ENALAPRIL MALEATE)
Proprietary Name: ENALAPRIL MALEATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213273
Product Number: 001
Approval Date: Jul 7, 2022
Applicant Holder Full Name: PRINSTON PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
5MG
Marketing Status: Prescription
Active Ingredient: ENALAPRIL MALEATE
Proprietary Name: ENALAPRIL MALEATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213273
Product Number: 002
Approval Date: Jul 7, 2022
Applicant Holder Full Name: PRINSTON PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
ENALAPRIL MALEATE (ENALAPRIL MALEATE)
Proprietary Name: ENALAPRIL MALEATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213273
Product Number: 002
Approval Date: Jul 7, 2022
Applicant Holder Full Name: PRINSTON PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
10MG
Marketing Status: Prescription
Active Ingredient: ENALAPRIL MALEATE
Proprietary Name: ENALAPRIL MALEATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213273
Product Number: 003
Approval Date: Jul 7, 2022
Applicant Holder Full Name: PRINSTON PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
ENALAPRIL MALEATE (ENALAPRIL MALEATE)
Proprietary Name: ENALAPRIL MALEATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213273
Product Number: 003
Approval Date: Jul 7, 2022
Applicant Holder Full Name: PRINSTON PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
20MG
Marketing Status: Prescription
Active Ingredient: ENALAPRIL MALEATE
Proprietary Name: ENALAPRIL MALEATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213273
Product Number: 004
Approval Date: Jul 7, 2022
Applicant Holder Full Name: PRINSTON PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: ENALAPRIL MALEATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213273
Product Number: 004
Approval Date: Jul 7, 2022
Applicant Holder Full Name: PRINSTON PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information