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BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents

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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Accenture
Cipla
Mallinckrodt
UBS
Chinese Patent Office
Fish and Richardson
Teva
Moodys
Cerilliant

Generated: December 17, 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 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 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 21695-575-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (21695-575-90)
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)

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:

Boehringer Ingelheim
Covington
Teva
AstraZeneca
Argus Health
QuintilesIMS
UBS
Fish and Richardson
Harvard Business School
Moodys

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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