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Details for New Drug Application (NDA): 075041

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NDA 075041 describes ISOSORBIDE MONONITRATE, which is a drug marketed by Actavis Elizabeth, Hikma Pharms, Dexcel Ltd, Alkermes Gainesville, Ani Pharms Inc, Ivax Sub Teva Pharms, Kremers Urban Pharms, Hikma Pharms Llc, Skyepharma Ag, Torrent Pharms, Nesher Pharms, and Vintage Pharms, and is included in fourteen NDAs. It is available from twenty-eight suppliers. Additional details are available on the ISOSORBIDE MONONITRATE profile page.

The generic ingredient in ISOSORBIDE MONONITRATE is isosorbide mononitrate. There are thirty-seven drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the isosorbide mononitrate profile page.

Summary for NDA: 075041

Alkermes Gainesville
isosorbide mononitrate
Therapeutic Class:Cardiovascular Agents

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG
Approval Date:Sep 22, 1998TE:RLD:No

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