Details for New Drug Application (NDA): 012093
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The generic ingredient in ISORDIL is isosorbide dinitrate. There are thirty-seven drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the isosorbide dinitrate profile page.
Summary for 012093
Tradename: | ISORDIL |
Applicant: | Bausch |
Ingredient: | isosorbide dinitrate |
Patents: | 0 |
Pharmacology for NDA: 012093
Physiological Effect | Vasodilation |
Medical Subject Heading (MeSH) Categories for 012093
Suppliers and Packaging for NDA: 012093
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ISORDIL | isosorbide dinitrate | TABLET;ORAL | 012093 | NDA | Bausch Health US LLC | 0187-0152 | 0187-0152-01 | 100 TABLET in 1 BOTTLE (0187-0152-01) |
ISORDIL | isosorbide dinitrate | TABLET;ORAL | 012093 | NDA | Bausch Health US LLC | 0187-0192 | 0187-0192-01 | 100 TABLET in 1 BOTTLE (0187-0192-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
Approval Date: | Jul 29, 1988 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Jul 29, 1988 | TE: | RLD: | Yes |
Profile for product number 005
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Jul 29, 1988 | TE: | RLD: | Yes |
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