BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Obtain formulation and manufacturing information
➤ 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:

Chinese Patent Office
Cantor Fitzgerald
Farmers Insurance
Queensland Health

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200624

« Back to Dashboard

NDA 200624 describes REPAGLINIDE AND METFORMIN HYDROCHLORIDE, which is a drug marketed by Lupin Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the REPAGLINIDE AND METFORMIN HYDROCHLORIDE profile page.

The generic ingredient in REPAGLINIDE AND METFORMIN HYDROCHLORIDE 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 200624
Applicant:Lupin Ltd
Ingredient:metformin hydrochloride; repaglinide
Formulation / Manufacturing:see details
Pharmacology for NDA: 200624
Mechanism of ActionPotassium Channel Antagonists
Suppliers and Packaging for NDA: 200624
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
REPAGLINIDE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; repaglinide TABLET;ORAL 200624 ANDA Lupin Pharmaceuticals, Inc. 68180-490 68180-490-03 1000 TABLET in 1 BOTTLE (68180-490-03)
REPAGLINIDE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; repaglinide TABLET;ORAL 200624 ANDA Lupin Pharmaceuticals, Inc. 68180-490 68180-490-02 500 TABLET in 1 BOTTLE (68180-490-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG;1MG
Approval Date:Jul 15, 2015TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG;2MG
Approval Date:Jul 15, 2015TE:RLD:No

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

Farmers Insurance
Johnson and Johnson
Cantor Fitzgerald
Chinese Patent Office

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.