Details for New Drug Application (NDA): 215988
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The generic ingredient in ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE 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 215988
Tradename: | ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE |
Applicant: | I3 Pharms |
Ingredient: | hydralazine hydrochloride; isosorbide dinitrate |
Patents: | 0 |
Pharmacology for NDA: 215988
Physiological Effect | Arteriolar Vasodilation Vasodilation |
Suppliers and Packaging for NDA: 215988
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride; isosorbide dinitrate | TABLET;ORAL | 215988 | ANDA | i3 Pharmaceuticals, LLC | 72319-012 | 72319-012-03 | 90 TABLET, FILM COATED in 1 BOTTLE (72319-012-03) |
ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride; isosorbide dinitrate | TABLET;ORAL | 215988 | ANDA | i3 Pharmaceuticals, LLC | 72319-012 | 72319-012-18 | 180 TABLET, FILM COATED in 1 BOTTLE (72319-012-18) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 37.5MG;20MG | ||||
Approval Date: | Jan 17, 2024 | TE: | AB | RLD: | No |
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