You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 21, 2024

Details for New Drug Application (NDA): 215988


✉ Email this page to a colleague

« Back to Dashboard


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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.