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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 205248

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NDA 205248 describes NATEGLINIDE, which is a drug marketed by Alvogen, Cadila Pharms Ltd, Dr Reddys Labs Ltd, Rising, Strides Pharma Intl, Teva Pharms, Watson Labs, and Zydus Pharms, and is included in eight NDAs. It is available from eleven suppliers. Additional details are available on the NATEGLINIDE profile page.

The generic ingredient in NATEGLINIDE is nateglinide. There are nine drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the nateglinide profile page.

Summary for 205248

Tradename:	NATEGLINIDE
Applicant:	Zydus Pharms
Ingredient:	nateglinide
Patents:	0

Pharmacology for NDA: 205248

Mechanism of Action	Potassium Channel Antagonists

Suppliers and Packaging for NDA: 205248

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NATEGLINIDE	nateglinide	TABLET;ORAL	205248	ANDA	Zydus Pharmaceuticals USA Inc.	68382-721	68382-721-01	100 TABLET, FILM COATED in 1 BOTTLE (68382-721-01)
NATEGLINIDE	nateglinide	TABLET;ORAL	205248	ANDA	Zydus Pharmaceuticals USA Inc.	68382-721	68382-721-05	500 TABLET, FILM COATED in 1 BOTTLE (68382-721-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	60MG
Approval Date:	Jul 6, 2016	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	120MG
Approval Date:	Jul 6, 2016	TE:	AB	RLD:	No

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