Last Updated: November 13, 2026

Details for New Drug Application (NDA): 205941

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NDA 205941 describes SAXAGLIPTIN, which is a drug marketed by Amneal, Aurobindo Pharma, Glenmark Pharms Ltd, Mylan, Sun Pharm, and Dr Reddys Labs Sa, and is included in eight NDAs. It is available from three suppliers. Additional details are available on the SAXAGLIPTIN profile page.

The generic ingredient in SAXAGLIPTIN is metformin hydrochloride; saxagliptin hydrochloride. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; saxagliptin hydrochloride profile page.

Summary for 205941

Tradename:	SAXAGLIPTIN
Applicant:	Amneal
Ingredient:	saxagliptin hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 2.5MG BASE
Approval Date:	Jul 31, 2023	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE
Approval Date:	Jul 31, 2023	TE:		RLD:	No

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