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Serving leading biopharmaceutical companies globally:

McKinsey
US Department of Justice
Express Scripts
Mallinckrodt
Deloitte
Fuji
Medtronic
Novartis
Farmers Insurance
Dow

Generated: October 22, 2017

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 Actavis Elizabeth, Hikma Pharms, Dexcel Ltd, Alkermes Gainesville, Ani Pharms Inc, Ivax Sub Teva Pharms, Kremers Urban Pharms, 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: 075155

Tradename:
1
Applicant:
1
Ingredient:
1
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 21695-575-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (21695-575-30)
ISOSORBIDE MONONITRATE
isosorbide mononitrate
TABLET, EXTENDED RELEASE;ORAL 075155 ANDA Rebel Distributors Corp 21695-575 21695-575-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (21695-575-90)

Summary for product number 001

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

Summary for product number 002

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

Summary 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 leading biopharmaceutical companies globally:

Accenture
Fish and Richardson
McKesson
Farmers Insurance
McKinsey
Harvard Business School
Covington
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Chubb
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