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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 087946


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NDA 087946 describes ISOSORBIDE DINITRATE, which is a drug marketed by Impax Labs Inc, Sun Pharm Inds Inc, Ani Pharms, Hikma Intl Pharms, Par Pharm, Par Pharm Inc, Rubicon, Sandoz, Sun Pharm Industries, Superpharm, Watson Labs, Zydus, Watson Labs Teva, I3 Pharms, and Riconpharma Llc, and is included in thirty-six NDAs. It is available from nineteen 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. Four suppliers are listed for this compound. Additional details are available on the hydralazine hydrochloride; isosorbide dinitrate profile page.
Summary for 087946
Tradename:ISOSORBIDE DINITRATE
Applicant:Par Pharm
Ingredient:isosorbide dinitrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 087946
Physiological EffectVasodilation
Medical Subject Heading (MeSH) Categories for 087946
Suppliers and Packaging for NDA: 087946
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;ORAL 087946 ANDA AvKARE 42291-350 42291-350-01 100 TABLET in 1 BOTTLE (42291-350-01)
ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;ORAL 087946 ANDA Par Pharmaceutical, Inc. 49884-009 49884-009-01 100 TABLET in 1 BOTTLE (49884-009-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Jan 12, 1988TE:ABRLD:No

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