Deeper Knowledge, Faster

  • Identify first generic entrants
  • Obtain formulation and manufacturing information
  • Drug patents in 130+ countries
➤ Start Trial

or, See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

QuintilesIMS
Covington
Chubb
Argus Health
Mallinckrodt
Queensland Health
Cantor Fitzgerald
Novartis
Dow
Julphar

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090598

« Back to Dashboard

NDA 090598 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 090598
Tradename:ISOSORBIDE MONONITRATE
Applicant:Vintage Pharms
Ingredient:isosorbide mononitrate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090598
Ingredient-typeNitrates
Physiological EffectVasodilation
Suppliers and Packaging for NDA: 090598
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISOSORBIDE MONONITRATE isosorbide mononitrate TABLET, EXTENDED RELEASE;ORAL 090598 ANDA Par Pharmaceutical 0603-4110 0603-4110-32 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0603-4110-32)
ISOSORBIDE MONONITRATE isosorbide mononitrate TABLET, EXTENDED RELEASE;ORAL 090598 ANDA Par Pharmaceutical 0603-4110 0603-4110-28 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0603-4110-28)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Aug 11, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG
Approval Date:Aug 11, 2010TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength120MG
Approval Date:Aug 11, 2010TE:ABRLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Covington
Healthtrust
McKinsey
Julphar
Chubb
Cerilliant
Medtronic
Chinese Patent Office
Citi

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.

botpot