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ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: I3 PHARMS · Approved 2024-01-17

Drug application

FDA Application #

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

Authoritative

Drugs@FDA application overview

Machine

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