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Generated: May 27, 2017

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Details for New Drug Application (NDA): 200495

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NDA 200495 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-two 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-two suppliers are listed for this compound. Additional details are available on the isosorbide mononitrate profile page.

Summary for NDA: 200495

Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 200495

Physiological EffectVasodilation

Suppliers and Packaging for NDA: 200495

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
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)

Summary for product number 001

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

Summary for product number 002

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

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