# ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE
> **ANDA215586** · Abbreviated New Drug Application (Generic) · Sponsor: INGENUS PHARMS LLC · Approved 2022-04-06
## Drug
- **FDA Application Number:** 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
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215586)
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