Product Details for NDA 012940
ISORDIL (ISOSORBIDE DINITRATE)
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ISOSORBIDE DINITRATE
Proprietary Name: ISORDIL
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N012940
Product Number: 004
Approval Date: Jul 29, 1988
Applicant Holder Full Name: BIOVAIL LABORATORIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
ISORDIL (ISOSORBIDE DINITRATE)
Proprietary Name: ISORDIL
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N012940
Product Number: 004
Approval Date: Jul 29, 1988
Applicant Holder Full Name: BIOVAIL LABORATORIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ISOSORBIDE DINITRATE
Proprietary Name: ISORDIL
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N012940
Product Number: 003
Approval Date: Jul 29, 1988
Applicant Holder Full Name: BIOVAIL LABORATORIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
ISORDIL (ISOSORBIDE DINITRATE)
Proprietary Name: ISORDIL
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: 5MG **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: N012940
Product Number: 003
Approval Date: Jul 29, 1988
Applicant Holder Full Name: BIOVAIL LABORATORIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ISOSORBIDE DINITRATE
Proprietary Name: ISORDIL
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: 10MG **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: N012940
Product Number: 005
Approval Date: Jul 29, 1988
Applicant Holder Full Name: BIOVAIL LABORATORIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: ISORDIL
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: 10MG **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: N012940
Product Number: 005
Approval Date: Jul 29, 1988
Applicant Holder Full Name: BIOVAIL LABORATORIES INC
Marketing Status: Discontinued
Patent and Exclusivity Information