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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 090153

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NDA 090153 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 090153

Tradename:	ZOLPIDEM TARTRATE
Applicant:	Actavis Labs Fl Inc
Ingredient:	zolpidem tartrate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	6.25MG
Approval Date:	Mar 25, 2013	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	12.5MG
Approval Date:	Mar 25, 2013	TE:		RLD:	No

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