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BioPharmaceutical Business Intelligence

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Serving 500+ biopharmaceutical companies globally:

US Army
AstraZeneca
Cantor Fitzgerald
Farmers Insurance
US Department of Justice
Teva
Chinese Patent Office
Argus Health
QuintilesIMS
McKinsey

Generated: September 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075522

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NDA 075522 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: 075522

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

Pharmacology for NDA: 075522

Ingredient-typeNitrates
Physiological EffectVasodilation

Suppliers and Packaging for NDA: 075522

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISOSORBIDE MONONITRATE
isosorbide mononitrate
TABLET, EXTENDED RELEASE;ORAL 075522 ANDA Heritage Pharmaceuticals Inc. 23155-178 23155-178-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-178-01)
ISOSORBIDE MONONITRATE
isosorbide mononitrate
TABLET, EXTENDED RELEASE;ORAL 075522 ANDA Heritage Pharmaceuticals Inc. 23155-178 23155-178-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-178-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG
Approval Date:Apr 17, 2000TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Sep 20, 2016TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Medtronic
Federal Trade Commission
Cipla
AstraZeneca
Deloitte
Colorcon
Cerilliant
Baxter
Fuji
Teva

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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