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Last Updated: November 24, 2024

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, 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 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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