Details for New Drug Application (NDA): 205994

NDA 205994 describes SAXAGLIPTIN, which is a drug marketed by Amneal, Aurobindo Pharma, Glenmark Pharms Ltd, Mylan, and Sun Pharm, and is included in seven 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 205994

Tradename:	SAXAGLIPTIN
Applicant:	Glenmark Pharms Ltd
Ingredient:	saxagliptin hydrochloride
Patents:	0

Pharmacology for NDA: 205994

Mechanism of Action

Dipeptidyl Peptidase 4 Inhibitors

Suppliers and Packaging for NDA: 205994

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	205994	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-726	68462-726-05	500 TABLET, FILM COATED in 1 BOTTLE (68462-726-05)
SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	205994	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-726	68462-726-30	30 TABLET, FILM COATED in 1 BOTTLE (68462-726-30)

Profile for product number 001

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

Profile for product number 002

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

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