Details for New Drug Application (NDA): 089367
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The generic ingredient in ISOSORBIDE DINITRATE is hydralazine hydrochloride; isosorbide dinitrate. There are twenty-one drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the hydralazine hydrochloride; isosorbide dinitrate profile page.
Summary for 089367
Tradename: | ISOSORBIDE DINITRATE |
Applicant: | Sandoz |
Ingredient: | isosorbide dinitrate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 089367
Physiological Effect | Vasodilation |
Medical Subject Heading (MeSH) Categories for 089367
Suppliers and Packaging for NDA: 089367
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ISOSORBIDE DINITRATE | isosorbide dinitrate | TABLET;ORAL | 089367 | ANDA | Sandoz Inc. | 0781-1695 | 0781-1695-01 | 100 TABLET in 1 BOTTLE (0781-1695-01) |
ISOSORBIDE DINITRATE | isosorbide dinitrate | TABLET;ORAL | 089367 | ANDA | Sandoz Inc. | 0781-1695 | 0781-1695-10 | 1000 TABLET in 1 BOTTLE (0781-1695-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Apr 7, 1988 | TE: | AB | RLD: | No |
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