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Generated: July 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204299

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NDA 204299 describes ZOLPIDEM TARTRATE, which is a drug marketed by Actavis Elizabeth, Actavis Labs Fl Inc, Anchen Pharms, Apotex Inc, Lupin Ltd, Sandoz, Sun Pharma Global, Synthon Pharms, Acme Labs, Aurobindo Pharma, Cipla Ltd, Dr Reddys Labs Ltd, Hikma, Invagen Pharms, Mylan, Mylan Pharms Inc, Sandoz Inc, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Torrent Pharms, Vintage, Vivimed Global, Watson Labs, Wockhardt, Yung Shin Pharm, Dr Reddys Labs Inc, Novel Labs Inc, Par Form, and Par Pharm Inc, and is included in thirty-four NDAs. It is available from fifty-seven 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. Sixty-four 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
Therapeutic Class:Sedatives/Hypnotics
Formulation / Manufacturing:see details
Pharmacology for NDA: 204299
Ingredient-typePyridines
Mechanism of ActionGABA A Agonists
Physiological EffectCentral 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 Novel Laboratories, Inc. 40032-761 N 40032-761-30
ZOLPIDEM TARTRATE zolpidem tartrate TABLET;SUBLINGUAL 204299 ANDA Novel Laboratories, Inc. 40032-762 N 40032-762-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrength1.75MG
Approval Date:Jun 3, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrength3.5MG
Approval Date:Jun 3, 2015TE:ABRLD:No

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