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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 204299

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NDA 204299 describes ZOLPIDEM TARTRATE, which is a drug marketed by Almatica, Actavis Elizabeth, Actavis Labs Fl Inc, Apotex, Breckenridge, Lupin Ltd, Ph Health, Sandoz, Sun Pharm, Synthon Pharms, Acme Labs, Anda Repository, Apotex Inc, Aurobindo Pharma, Chartwell Molecular, Hikma, Invagen Pharms, Mylan Pharms Inc, Rising, Strides Pharma, Strides Pharma Intl, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Torrent Pharms, Watson Labs, Wockhardt, Yung Shin Pharm, Dr Reddys, Novel Labs Inc, and Pharmobedient, 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-seven suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.

Summary for 204299

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

Pharmacology for NDA: 204299

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

Suppliers and Packaging for NDA: 204299

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZOLPIDEM TARTRATE	zolpidem tartrate	TABLET;SUBLINGUAL	204299	ANDA	Lupin Pharmaceuticals,Inc.	43386-761	43386-761-30	30 POUCH in 1 CARTON (43386-761-30) / 1 BLISTER PACK in 1 POUCH (43386-761-01) / 1 TABLET in 1 BLISTER PACK
ZOLPIDEM TARTRATE	zolpidem tartrate	TABLET;SUBLINGUAL	204299	ANDA	Lupin Pharmaceuticals,Inc.	43386-762	43386-762-30	30 POUCH in 1 CARTON (43386-762-30) / 1 BLISTER PACK in 1 POUCH (43386-762-01) / 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;SUBLINGUAL			Strength	1.75MG
Approval Date:	Jun 3, 2015	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;SUBLINGUAL			Strength	3.5MG
Approval Date:	Jun 3, 2015	TE:	AB	RLD:	No

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