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Last Updated: December 12, 2025

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 four suppliers. Additional details are available on the SAXAGLIPTIN profile page.

The generic ingredient in SAXAGLIPTIN is metformin hydrochloride; saxagliptin hydrochloride. There are forty-nine drug master file entries for this compound. Three 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

Pharmacology for NDA: 205941

Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors

Suppliers and Packaging for NDA: 205941

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	205941	ANDA	Amneal Pharmaceuticals LLC	65162-059	65162-059-03	30 TABLET, FILM COATED in 1 BOTTLE (65162-059-03)
SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	205941	ANDA	Amneal Pharmaceuticals LLC	65162-059	65162-059-09	90 TABLET, FILM COATED in 1 BOTTLE (65162-059-09)

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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