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Serving leading biopharmaceutical companies globally:

US Department of Justice
UBS
Cantor Fitzgerald
US Army
Colorcon
Harvard Business School
Teva
Baxter
AstraZeneca
Boehringer Ingelheim

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075361

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NDA 075361 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 thirty-one 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. Thirty-one suppliers are listed for this compound. Additional details are available on the isosorbide mononitrate profile page.
Summary for 075361
Tradename:ISOSORBIDE MONONITRATE
Applicant:Hikma Pharms
Ingredient:isosorbide mononitrate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 075361
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISOSORBIDE MONONITRATE isosorbide mononitrate TABLET;ORAL 075361 ANDA West-ward Pharmaceutical Corp 0143-1333 0143-1333-09 90 TABLET, COATED in 1 BOTTLE (0143-1333-09)
ISOSORBIDE MONONITRATE isosorbide mononitrate TABLET;ORAL 075361 ANDA West-ward Pharmaceutical Corp 0143-1333 0143-1333-30 30 TABLET, COATED in 1 BOTTLE (0143-1333-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Oct 5, 2000TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Chubb
Cerilliant
Chinese Patent Office
McKesson
Citi
Queensland Health
Fuji
Express Scripts

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