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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 078483

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NDA 078483 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-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-six suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.

Summary for 078483

Tradename:	ZOLPIDEM TARTRATE
Applicant:	Synthon Pharms
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:	Apr 12, 2011	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	12.5MG
Approval Date:	Jun 6, 2011	TE:		RLD:	No

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