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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Cantor Fitzgerald
Healthtrust
Daiichi Sankyo
Dow
UBS
McKesson
Federal Trade Commission
US Army

Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075155

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NDA 075155 describes ISOSORBIDE MONONITRATE, which is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Alkermes Gainesville, Dexcel Ltd, Hikma Pharms, Ivax Sub Teva Pharms, Lannett Co Inc, 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 075155
Tradename:ISOSORBIDE MONONITRATE
Applicant:Lannett Co Inc
Ingredient:isosorbide mononitrate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075155
Ingredient-typeNitrates
Physiological EffectVasodilation
Suppliers and Packaging for NDA: 075155
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISOSORBIDE MONONITRATE isosorbide mononitrate TABLET, EXTENDED RELEASE;ORAL 075155 ANDA Rebel Distributors Corp 21695-575 E 21695-575-30
ISOSORBIDE MONONITRATE isosorbide mononitrate TABLET, EXTENDED RELEASE;ORAL 075155 ANDA Rebel Distributors Corp 21695-575 E 21695-575-90

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG
Approval Date:Oct 30, 1998TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Jan 13, 2000TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength120MG
Approval Date:Aug 4, 2000TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Accenture
Farmers Insurance
Chinese Patent Office
Boehringer Ingelheim
Colorcon
Argus Health
US Department of Justice
Covington

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