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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 076410

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NDA 076410 describes ZOLPIDEM TARTRATE, which is a drug marketed by Almatica, Actavis Elizabeth, Actavis Labs Fl Inc, Apotex, Breckenridge, Endo Operations, Lupin Ltd, Sandoz, Sun Pharm, Synthon Pharms, Acme Labs, Apotex Inc, Aurobindo Pharma, Chartwell Molecular, Dr Reddys Labs Ltd, Hikma, Invagen Pharms, Mylan Pharms Inc, Rising, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Torrent Pharms, Watson Labs, Wockhardt, Yung Shin Pharm, Dr Reddys, Norvium Bioscience, and Novel Labs Inc, and is included in thirty-six NDAs. It is available from forty-five 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 076410

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

Pharmacology for NDA: 076410

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

Suppliers and Packaging for NDA: 076410

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZOLPIDEM TARTRATE	zolpidem tartrate	TABLET;ORAL	076410	ANDA	Teva Pharmaceuticals USA, Inc.	0093-0073	0093-0073-01	100 TABLET, FILM COATED in 1 BOTTLE (0093-0073-01)
ZOLPIDEM TARTRATE	zolpidem tartrate	TABLET;ORAL	076410	ANDA	Teva Pharmaceuticals USA, Inc.	0093-0074	0093-0074-01	100 TABLET, FILM COATED in 1 BOTTLE (0093-0074-01)

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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