Details for New Drug Application (NDA): 086923
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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. Six suppliers are listed for this compound. Additional details are available on the hydralazine hydrochloride; isosorbide dinitrate profile page.
Summary for 086923
Tradename: | ISOSORBIDE DINITRATE |
Applicant: | Endo Operations |
Ingredient: | isosorbide dinitrate |
Patents: | 0 |
Pharmacology for NDA: 086923
Physiological Effect | Vasodilation |
Medical Subject Heading (MeSH) Categories for 086923
Suppliers and Packaging for NDA: 086923
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ISOSORBIDE DINITRATE | isosorbide dinitrate | TABLET;ORAL | 086923 | ANDA | Endo USA, Inc. | 49884-020 | 49884-020-01 | 100 TABLET in 1 BOTTLE (49884-020-01) |
ISOSORBIDE DINITRATE | isosorbide dinitrate | TABLET;ORAL | 086923 | ANDA | Endo USA, Inc. | 49884-020 | 49884-020-10 | 1000 TABLET in 1 BOTTLE (49884-020-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Mar 12, 1987 | TE: | AB | RLD: | No |
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