Product Details for NDA 020528
MAVIK (TRANDOLAPRIL)
1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: TRANDOLAPRIL
Proprietary Name: MAVIK
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020528
Product Number: 001
Approval Date: Apr 26, 1996
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
MAVIK (TRANDOLAPRIL)
Proprietary Name: MAVIK
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020528
Product Number: 001
Approval Date: Apr 26, 1996
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: TRANDOLAPRIL
Proprietary Name: MAVIK
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020528
Product Number: 002
Approval Date: Apr 26, 1996
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
MAVIK (TRANDOLAPRIL)
Proprietary Name: MAVIK
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020528
Product Number: 002
Approval Date: Apr 26, 1996
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: TRANDOLAPRIL
Proprietary Name: MAVIK
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG **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: N020528
Product Number: 003
Approval Date: Apr 26, 1996
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: MAVIK
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG **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: N020528
Product Number: 003
Approval Date: Apr 26, 1996
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Discontinued
Patent and Exclusivity Information