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Generated: March 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 084204

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NDA 084204 describes ISOSORBIDE DINITRATE, which is a drug marketed by Impax Labs Inc, Sun Pharm Inds Inc, Hikma Intl Pharms, Par Pharm, Sandoz, Sun Pharm Industries, Superpharm, Watson Labs, and Watson Labs Teva, and is included in thirty-one NDAs. It is available from twenty-three 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-five suppliers are listed for this compound. Additional details are available on the isosorbide dinitrate profile page.
Summary for 084204
Applicant:Sun Pharm Industries
Ingredient:isosorbide dinitrate
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 084204

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;SUBLINGUALStrength2.5MG
Approval Date:Sep 18, 1986TE:RLD:No

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