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Last Updated: November 25, 2024

Details for New Drug Application (NDA): 086923


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NDA 086923 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 086923
Tradename:ISOSORBIDE DINITRATE
Applicant:Endo Operations
Ingredient:isosorbide dinitrate
Patents:0
Pharmacology for NDA: 086923
Physiological EffectVasodilation
Medical Subject Heading (MeSH) Categories for 086923
Suppliers and Packaging for NDA: 086923
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;ORAL 086923 ANDA Endo USA, Inc. 49884-020 49884-020-01 100 TABLET in 1 BOTTLE (49884-020-01)
ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;ORAL 086923 ANDA Endo USA, Inc. 49884-020 49884-020-10 1000 TABLET in 1 BOTTLE (49884-020-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Mar 12, 1987TE:ABRLD:No

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