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Serving 500+ biopharmaceutical companies globally:

Julphar
Cantor Fitzgerald
Merck
Colorcon
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Healthtrust
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Generated: August 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200270

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NDA 200270 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 thirty 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 suppliers are listed for this compound. Additional details are available on the isosorbide mononitrate profile page.

Summary for NDA: 200270

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 200270

Ingredient-typeNitrates
Physiological EffectVasodilation

Suppliers and Packaging for NDA: 200270

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISOSORBIDE MONONITRATE
isosorbide mononitrate
TABLET, EXTENDED RELEASE;ORAL 200270 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7767 0615-7767-05 15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-7767-05)
ISOSORBIDE MONONITRATE
isosorbide mononitrate
TABLET, EXTENDED RELEASE;ORAL 200270 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7767 0615-7767-39 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-7767-39)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Jun 3, 2011TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Julphar
Daiichi Sankyo
Teva
Citi
Merck
Boehringer Ingelheim
Medtronic
Novartis
Queensland Health
QuintilesIMS

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