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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Harvard Business School
Colorcon
Boehringer Ingelheim
Queensland Health
Deloitte
Chinese Patent Office
McKinsey
Covington

Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075522

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NDA 075522 describes ISOSORBIDE MONONITRATE, which is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Alkermes Gainesville, Dexcel Ltd, Hikma Pharms, Ivax Sub Teva Pharms, Kremers Urban Pharms, Nesher Pharms, Skyepharma Ag, Torrent Pharms, Vintage Pharms, and Ani Pharms Inc, and is included in fifteen 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 075522
Tradename:ISOSORBIDE MONONITRATE
Applicant:Dexcel Ltd
Ingredient:isosorbide mononitrate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075522
Ingredient-typeNitrates
Physiological EffectVasodilation
Suppliers and Packaging for NDA: 075522
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISOSORBIDE MONONITRATE isosorbide mononitrate TABLET, EXTENDED RELEASE;ORAL 075522 ANDA Heritage Pharmaceuticals Inc. 23155-178 N 23155-178-09
ISOSORBIDE MONONITRATE isosorbide mononitrate TABLET, EXTENDED RELEASE;ORAL 075522 ANDA Heritage Pharmaceuticals Inc. 23155-178 N 23155-178-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG
Approval Date:Apr 17, 2000TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Sep 20, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Deloitte
Medtronic
Baxter
Johnson and Johnson
Argus Health
QuintilesIMS
Healthtrust
Fuji

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