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Last Updated: August 12, 2020

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Details for New Drug Application (NDA): 087545

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NDA 087545 describes ISOSORBIDE DINITRATE, which is a drug marketed by Impax Labs Inc, Sun Pharm Inds Inc, Ani Pharms Inc, Hikma Intl Pharms, Par Pharm, Sandoz, Sun Pharm Industries, Superpharm, Watson Labs, Zydus, and Watson Labs Teva, and is included in thirty-two NDAs. It is available from seventeen suppliers. Additional details are available on the ISOSORBIDE DINITRATE profile page.

The generic ingredient in ISOSORBIDE DINITRATE is isosorbide dinitrate. There are thirty-seven drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the isosorbide dinitrate profile page.
Summary for 087545
Tradename:ISOSORBIDE DINITRATE
Applicant:Sun Pharm Industries
Ingredient:isosorbide dinitrate
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 087545

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;SUBLINGUALStrength10MG
Approval Date:Sep 18, 1986TE:RLD:No

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