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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 215721

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NDA 215721 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-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-five suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.

Summary for 215721

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

Pharmacology for NDA: 215721

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

Suppliers and Packaging for NDA: 215721

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZOLPIDEM TARTRATE	zolpidem tartrate	CAPSULE;ORAL	215721	NDA	Almatica Pharma LLC	52427-775	52427-775-30	30 CAPSULE in 1 BOTTLE (52427-775-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	7.5MG
Approval Date:	May 9, 2023	TE:		RLD:	Yes

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