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ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: INGENUS PHARMS LLC · Approved 2022-04-06
Drug application
- FDA Application #
ANDA215586- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE
- Generic name
- ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE
- Active ingredients
- HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- INGENUS PHARMS LLC
- Manufacturer
- Ingenus Pharmaceuticals, LLC
- First approval
- 2022-04-06
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown