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

Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
AstraZeneca
Cipla
Medtronic
Covington
McKinsey
Colorcon
Cantor Fitzgerald
QuintilesIMS

Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203820

« Back to Dashboard

NDA 203820 describes REPAGLINIDE, which is a drug marketed by Actavis Totowa, Aurobindo Pharma Ltd, Boscogen, Casi Pharms Inc, Mylan Pharms Inc, Paddock Llc, Sun Pharm Inds Inc, and Lupin Ltd, and is included in eight NDAs. It is available from twelve suppliers. Additional details are available on the REPAGLINIDE profile page.

The generic ingredient in REPAGLINIDE is metformin hydrochloride; repaglinide. There are forty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the metformin hydrochloride; repaglinide profile page.
Summary for 203820
Tradename:REPAGLINIDE
Applicant:Aurobindo Pharma Ltd
Ingredient:repaglinide
Patents:0
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details
Pharmacology for NDA: 203820
Mechanism of ActionPotassium Channel Antagonists
Suppliers and Packaging for NDA: 203820
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
REPAGLINIDE repaglinide TABLET;ORAL 203820 ANDA Rising Health, LLC 57237-157 N 57237-157-01
REPAGLINIDE repaglinide TABLET;ORAL 203820 ANDA Rising Health, LLC 57237-157 N 57237-157-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Jan 22, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Jan 22, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Jan 22, 2014TE:ABRLD:No

Complete Access Available with Subscription

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

Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
McKesson
Julphar
Citi
Johnson and Johnson
Deloitte
Dow
Fish and Richardson
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.