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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 204503

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NDA 204503 describes ZOLPIDEM TARTRATE, which is a drug marketed by Almatica, Actavis Elizabeth, Actavis Labs Fl Inc, Apotex, Breckenridge, Lupin Ltd, Ph Health, Sandoz, Sun Pharm, Synthon Pharms, Acme Labs, Anda Repository, Apotex Inc, Aurobindo Pharma, Chartwell Molecular, Hikma, Invagen Pharms, Mylan Pharms Inc, Rising, Strides Pharma, Strides Pharma Intl, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Torrent Pharms, Watson Labs, Wockhardt, Yung Shin Pharm, Dr Reddys, Novel Labs Inc, and Pharmobedient, and is included in thirty-six NDAs. It is available from forty-four suppliers. Additional details are available on the ZOLPIDEM TARTRATE profile page.

The generic ingredient in ZOLPIDEM TARTRATE is zolpidem tartrate. There are thirty-three drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.

Summary for 204503

Tradename:	ZOLPIDEM TARTRATE
Applicant:	Dr Reddys
Ingredient:	zolpidem tartrate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;SUBLINGUAL			Strength	1.75MG
Approval Date:	Nov 18, 2016	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;SUBLINGUAL			Strength	3.5MG
Approval Date:	Nov 18, 2016	TE:	AB	RLD:	No

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