You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 19, 2024

Details for New Drug Application (NDA): 076813


✉ Email this page to a colleague

« Back to Dashboard


NDA 076813 describes ISOSORBIDE MONONITRATE, which is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Alkermes Gainesville, Aurobindo Pharma, Chartwell Molecular, Dexcel Ltd, Hikma Intl Pharms, Ivax Sub Teva Pharms, Riconpharma Llc, Shandong, Skyepharma Ag, Strides Pharma, Torrent Pharms, Zydus Hlthcare, Ani Pharms, and Hikma Pharms, and is included in nineteen NDAs. It is available from twenty-three 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. Twenty-three suppliers are listed for this compound. Additional details are available on the isosorbide mononitrate profile page.
Summary for 076813
Tradename:ISOSORBIDE MONONITRATE
Applicant:Hikma Intl Pharms
Ingredient:isosorbide mononitrate
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG
Approval Date:Jan 7, 2005TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Mar 30, 2006TE:RLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.