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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 086925


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NDA 086925 describes ISOSORBIDE DINITRATE, which is a drug marketed by Impax Labs Inc, Sun Pharm Inds Inc, Ani Pharms, Endo Operations, Hikma Intl Pharms, Rubicon, Sandoz, Sun Pharm Industries, Superpharm, Watson Labs, Zydus Lifesciences, Watson Labs Teva, I3 Pharms, and Riconpharma Llc, and is included in thirty-six NDAs. It is available from twenty suppliers. Additional details are available on the ISOSORBIDE DINITRATE profile page.

The generic ingredient in ISOSORBIDE DINITRATE 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.
Summary for 086925
Tradename:ISOSORBIDE DINITRATE
Applicant:Endo Operations
Ingredient:isosorbide dinitrate
Patents:0
Pharmacology for NDA: 086925
Physiological EffectVasodilation
Medical Subject Heading (MeSH) Categories for 086925
Suppliers and Packaging for NDA: 086925
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;ORAL 086925 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-139 43353-139-60 90 TABLET in 1 BOTTLE (43353-139-60)
ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;ORAL 086925 ANDA Endo USA, Inc. 49884-021 49884-021-01 100 TABLET in 1 BOTTLE (49884-021-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Mar 12, 1987TE:ABRLD:No

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