Product Details for NDA 019787
NORVASC (AMLODIPINE BESYLATE)
EQ 2.5MG BASE
Marketing Status: Prescription
EQ 5MG BASE
Marketing Status: Prescription
EQ 10MG BASE
Marketing Status: Prescription
EQ 2.5MG BASE
Marketing Status: Prescription
Active Ingredient: AMLODIPINE BESYLATE
Proprietary Name: NORVASC
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 2.5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019787
Product Number: 001
Approval Date: Jul 31, 1992
Applicant Holder Full Name: VIATRIS SPECIALTY LLC
Marketing Status: Prescription
Patent and Exclusivity Information
NORVASC (AMLODIPINE BESYLATE)
Proprietary Name: NORVASC
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 2.5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019787
Product Number: 001
Approval Date: Jul 31, 1992
Applicant Holder Full Name: VIATRIS SPECIALTY LLC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 5MG BASE
Marketing Status: Prescription
Active Ingredient: AMLODIPINE BESYLATE
Proprietary Name: NORVASC
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019787
Product Number: 002
Approval Date: Jul 31, 1992
Applicant Holder Full Name: VIATRIS SPECIALTY LLC
Marketing Status: Prescription
Patent and Exclusivity Information
NORVASC (AMLODIPINE BESYLATE)
Proprietary Name: NORVASC
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019787
Product Number: 002
Approval Date: Jul 31, 1992
Applicant Holder Full Name: VIATRIS SPECIALTY LLC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 10MG BASE
Marketing Status: Prescription
Active Ingredient: AMLODIPINE BESYLATE
Proprietary Name: NORVASC
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N019787
Product Number: 003
Approval Date: Jul 31, 1992
Applicant Holder Full Name: VIATRIS SPECIALTY LLC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: NORVASC
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N019787
Product Number: 003
Approval Date: Jul 31, 1992
Applicant Holder Full Name: VIATRIS SPECIALTY LLC
Marketing Status: Prescription
Patent and Exclusivity Information