Suppliers and packages for generic ingredient: HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE
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HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Azurity | BIDIL | hydralazine hydrochloride; isosorbide dinitrate | TABLET;ORAL | 020727 | NDA | Azurity | 24338-010-09 | 90 TABLET, FILM COATED in 1 BOTTLE (24338-010-09) | 2012-12-05 |
| Azurity | BIDIL | hydralazine hydrochloride; isosorbide dinitrate | TABLET;ORAL | 020727 | NDA AUTHORIZED GENERIC | Wilshire Pharmaceuticals | 52536-006-09 | 90 TABLET, FILM COATED in 1 BOTTLE (52536-006-09) | 2022-04-15 |
| I3 Pharms | ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride; isosorbide dinitrate | TABLET;ORAL | 215988 | ANDA | i3 Pharmaceuticals, LLC | 72319-012-03 | 90 TABLET, FILM COATED in 1 BOTTLE (72319-012-03) | 2024-02-07 |
| I3 Pharms | ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride; isosorbide dinitrate | TABLET;ORAL | 215988 | ANDA | i3 Pharmaceuticals, LLC | 72319-012-18 | 180 TABLET, FILM COATED in 1 BOTTLE (72319-012-18) | 2024-02-07 |
| Riconpharma Llc | ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride; isosorbide dinitrate | TABLET;ORAL | 215586 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-246-18 | 180 TABLET in 1 BOTTLE (50742-246-18) | 2022-02-12 |
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