# ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE
> **ANDA215988** · Abbreviated New Drug Application (Generic) · Sponsor: I3 PHARMS · Approved 2024-01-17
## Drug
- **FDA Application Number:** ANDA215988
- **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:** I3 PHARMS
- **Manufacturer:** A2A Integrated Pharmaceuticals
- **First approval:** 2024-01-17
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215988)
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