Product Details for NDA 020591
TARKA (TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE)
1MG;240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
2MG;180MG
Marketing Status: Discontinued
2MG;240MG
Marketing Status: Discontinued
4MG;240MG
Marketing Status: Discontinued
1MG;240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE
Proprietary Name: TARKA
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 1MG;240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020591
Product Number: 003
Approval Date: Oct 22, 1996
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
TARKA (TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE)
Proprietary Name: TARKA
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 1MG;240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020591
Product Number: 003
Approval Date: Oct 22, 1996
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
2MG;180MG
Marketing Status: Discontinued
Active Ingredient: TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE
Proprietary Name: TARKA
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 2MG;180MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020591
Product Number: 001
Approval Date: Oct 22, 1996
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
TARKA (TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE)
Proprietary Name: TARKA
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 2MG;180MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020591
Product Number: 001
Approval Date: Oct 22, 1996
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
2MG;240MG
Marketing Status: Discontinued
Active Ingredient: TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE
Proprietary Name: TARKA
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 2MG;240MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020591
Product Number: 004
Approval Date: Oct 22, 1996
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
TARKA (TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE)
Proprietary Name: TARKA
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 2MG;240MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020591
Product Number: 004
Approval Date: Oct 22, 1996
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
4MG;240MG
Marketing Status: Discontinued
Active Ingredient: TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE
Proprietary Name: TARKA
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 4MG;240MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020591
Product Number: 002
Approval Date: Oct 22, 1996
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: TARKA
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 4MG;240MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020591
Product Number: 002
Approval Date: Oct 22, 1996
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Discontinued
Patent and Exclusivity Information