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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 205544

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NDA 205544 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 205544

Tradename:	NATEGLINIDE
Applicant:	Rising
Ingredient:	nateglinide
Patents:	0

Pharmacology for NDA: 205544

Mechanism of Action	Potassium Channel Antagonists

Suppliers and Packaging for NDA: 205544

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NATEGLINIDE	nateglinide	TABLET;ORAL	205544	ANDA	Rising Pharma Holdings, Inc.	16571-758	16571-758-01	100 TABLET in 1 BOTTLE (16571-758-01)
NATEGLINIDE	nateglinide	TABLET;ORAL	205544	ANDA	Rising Pharma Holdings, Inc.	16571-758	16571-758-09	90 TABLET in 1 BOTTLE (16571-758-09)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	60MG
Approval Date:	Jun 18, 2018	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	120MG
Approval Date:	Jun 18, 2018	TE:	AB	RLD:	No

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