You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 26, 2026

Details for New Drug Application (NDA): 207209

✉ Email this page to a colleague

« Back to Dashboard

NDA 207209 describes REPAGLINIDE, which is a drug marketed by Actavis Totowa, Aurobindo Pharma Ltd, Chartwell Rx, Kenton, Macleods Pharms Ltd, Padagis Us, Quagen, Sun Pharm Inds Inc, and Lupin Ltd, and is included in nine 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 207209

Tradename:	REPAGLINIDE
Applicant:	Macleods Pharms Ltd
Ingredient:	repaglinide
Patents:	0

Pharmacology for NDA: 207209

Mechanism of Action	Potassium Channel Antagonists

Suppliers and Packaging for NDA: 207209

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
REPAGLINIDE	repaglinide	TABLET;ORAL	207209	ANDA	Macleods Pharmaceuticals Limited	33342-248	33342-248-11	100 TABLET in 1 BOTTLE (33342-248-11)
REPAGLINIDE	repaglinide	TABLET;ORAL	207209	ANDA	Macleods Pharmaceuticals Limited	33342-248	33342-248-44	1000 TABLET in 1 BOTTLE (33342-248-44)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Mar 22, 2023	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Mar 22, 2023	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Mar 22, 2023	TE:	AB	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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.