You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 22, 2024

Details for New Drug Application (NDA): 215721

✉ Email this page to a colleague

« Back to Dashboard

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-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 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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.