U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 012093

Expand all

ISORDIL (ISOSORBIDE DINITRATE)
5MG
Marketing Status: Prescription
Active Ingredient: ISOSORBIDE DINITRATE
Proprietary Name: ISORDIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N012093
Product Number: 007
Approval Date: Jul 29, 1988
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
ISORDIL (ISOSORBIDE DINITRATE)
40MG
Marketing Status: Prescription
Active Ingredient: ISOSORBIDE DINITRATE
Proprietary Name: ISORDIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 40MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N012093
Product Number: 001
Approval Date: Jul 29, 1988
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
ISORDIL (ISOSORBIDE DINITRATE)
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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; ORAL
Strength: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N012093
Product Number: 002
Approval Date: Jul 29, 1988
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
ISORDIL (ISOSORBIDE DINITRATE)
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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; ORAL
Strength: 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N012093
Product Number: 006
Approval Date: Jul 29, 1988
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
ISORDIL (ISOSORBIDE DINITRATE)
30MG **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; ORAL
Strength: 30MG **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: N012093
Product Number: 005
Approval Date: Jul 29, 1988
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
Back to Top