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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 215988


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NDA 215988 describes ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE, which is a drug marketed by I3 Pharms and Riconpharma Llc and is included in two NDAs. It is available from three suppliers. Additional details are available on the ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE profile page.

The generic ingredient in ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE is hydralazine hydrochloride; isosorbide dinitrate. There are twenty-one drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the hydralazine hydrochloride; isosorbide dinitrate profile page.
Pharmacology for NDA: 215988
Suppliers and Packaging for NDA: 215988
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride; isosorbide dinitrate TABLET;ORAL 215988 ANDA i3 Pharmaceuticals, LLC 72319-012 72319-012-03 90 TABLET, FILM COATED in 1 BOTTLE (72319-012-03)
ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride; isosorbide dinitrate TABLET;ORAL 215988 ANDA i3 Pharmaceuticals, LLC 72319-012 72319-012-18 180 TABLET, FILM COATED in 1 BOTTLE (72319-012-18)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength37.5MG;20MG
Approval Date:Jan 17, 2024TE:ABRLD:No

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