You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Moodys
Dow
Harvard Business School
Colorcon
AstraZeneca
Medtronic

Last Updated: September 27, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201189

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

NDA 201189 describes REPAGLINIDE, which is a drug marketed by Actavis Totowa, Aurobindo Pharma Ltd, Boscogen, Casi Pharms Inc, Mylan, Paddock Llc, Sun Pharm Inds Inc, and Lupin Ltd, and is included in eight NDAs. It is available from seven suppliers. Additional details are available on the REPAGLINIDE profile page.

The generic ingredient in REPAGLINIDE is metformin hydrochloride; repaglinide. There are forty-nine drug master file entries for this compound. Additional details are available on the metformin hydrochloride; repaglinide profile page.
Summary for 201189
Tradename:REPAGLINIDE
Applicant:Paddock Llc
Ingredient:repaglinide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 201189
Mechanism of ActionPotassium Channel Antagonists
Suppliers and Packaging for NDA: 201189
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
REPAGLINIDE repaglinide TABLET;ORAL 201189 ANDA Paddock Laboratories, LLC 0574-0240 0574-0240-01 100 TABLET in 1 BOTTLE (0574-0240-01)
REPAGLINIDE repaglinide TABLET;ORAL 201189 ANDA Paddock Laboratories, LLC 0574-0241 0574-0241-01 100 TABLET in 1 BOTTLE (0574-0241-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Jul 17, 2013TE: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

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

Serving leading biopharmaceutical companies globally:

McKinsey
Johnson and Johnson
Harvard Business School
AstraZeneca
McKesson
Colorcon

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.