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Last Updated: April 1, 2026

Details for New Drug Application (NDA): 077322

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NDA 077322 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, Apotex Inc, Aurobindo Pharma, Chartwell Molecular, Hikma, Invagen Pharms, Mylan Pharms Inc, Rising, Senores Pharms, 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-three 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-six suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.

Summary for 077322

Tradename:	ZOLPIDEM TARTRATE
Applicant:	Sandoz
Ingredient:	zolpidem tartrate
Patents:	0

Pharmacology for NDA: 077322

Mechanism of Action	GABA A Receptor Positive Modulators
Physiological Effect	Central Nervous System Depression

Suppliers and Packaging for NDA: 077322

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZOLPIDEM TARTRATE	zolpidem tartrate	TABLET;ORAL	077322	ANDA	Sandoz Inc	0781-5317	0781-5317-01	100 TABLET, COATED in 1 BOTTLE (0781-5317-01)
ZOLPIDEM TARTRATE	zolpidem tartrate	TABLET;ORAL	077322	ANDA	Sandoz Inc	0781-5317	0781-5317-05	500 TABLET, COATED in 1 BOTTLE (0781-5317-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Apr 23, 2007	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Apr 23, 2007	TE:	AB	RLD:	No

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