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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
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US Department of Justice
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Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200495

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NDA 200495 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 200495
Tradename:ISOSORBIDE MONONITRATE
Applicant:Torrent Pharms
Ingredient:isosorbide mononitrate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 200495
Ingredient-typeNitrates
Physiological EffectVasodilation
Suppliers and Packaging for NDA: 200495
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISOSORBIDE MONONITRATE isosorbide mononitrate TABLET, EXTENDED RELEASE;ORAL 200495 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7768 0615-7768-05 15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-7768-05)
ISOSORBIDE MONONITRATE isosorbide mononitrate TABLET, EXTENDED RELEASE;ORAL 200495 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7768 0615-7768-39 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-7768-39)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG
Approval Date:Jun 3, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength120MG
Approval Date:Jun 3, 2011TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Dow
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Argus Health
Medtronic
Accenture
Colorcon
Mallinckrodt
Johnson and Johnson
Citi

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