Details for New Drug Application (NDA): 012093
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NDA 012093 describes ISORDIL, which is a drug marketed by Wyeth Ayerst, Bausch, and Biovail, and is included in three NDAs. It is available from two suppliers. Additional details are available on the ISORDIL profile page.
The generic ingredient in ISORDIL is isosorbide dinitrate. There are thirty-seven drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the isosorbide dinitrate profile page.
The generic ingredient in ISORDIL is isosorbide dinitrate. There are thirty-seven drug master file entries for this compound. Twenty-one 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 |
| Formulation / Manufacturing: | see details |
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| DISCN | Dosage: | TABLET;ORAL | Strength | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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| DISCN | Dosage: | TABLET;ORAL | Strength | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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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