Details for New Drug Application (NDA): 086925
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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 086925
Tradename: | ISOSORBIDE DINITRATE |
Applicant: | Endo Operations |
Ingredient: | isosorbide dinitrate |
Patents: | 0 |
Pharmacology for NDA: 086925
Physiological Effect | Vasodilation |
Medical Subject Heading (MeSH) Categories for 086925
Suppliers and Packaging for NDA: 086925
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ISOSORBIDE DINITRATE | isosorbide dinitrate | TABLET;ORAL | 086925 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-139 | 43353-139-60 | 90 TABLET in 1 BOTTLE (43353-139-60) |
ISOSORBIDE DINITRATE | isosorbide dinitrate | TABLET;ORAL | 086925 | ANDA | Endo USA, Inc. | 49884-021 | 49884-021-01 | 100 TABLET in 1 BOTTLE (49884-021-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Mar 12, 1987 | TE: | AB | RLD: | No |
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