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Generated: December 13, 2017

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, Allied Pharma Inc, 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-eight suppliers. Additional details are available on the ZOLPIDEM TARTRATE profile page.

The generic ingredient in ZOLPIDEM TARTRATE is zolpidem tartrate. There are thirty-one drug master file entries for this compound. Sixty-six suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.

Summary for 204299

Tradename:1
Applicant:1
Ingredient:1
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 40032-761-30 30 POUCH in 1 CARTON (40032-761-30) > 1 BLISTER PACK in 1 POUCH (40032-761-01) > 1 TABLET in 1 BLISTER PACK
ZOLPIDEM TARTRATE zolpidem tartrate TABLET;SUBLINGUAL 204299 ANDA Novel Laboratories, Inc. 40032-762 40032-762-30 30 POUCH in 1 CARTON (40032-762-30) > 1 BLISTER PACK in 1 POUCH (40032-762-01) > 1 TABLET in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrength1.75MG
Approval Date:Jun 3, 2015TE:ABRLD:No
Regulatory Exclusivity Expiration:Sep 18, 2016
Regulatory Exclusivity Use:PATENT CHALLENGE

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrength3.5MG
Approval Date:Jun 3, 2015TE:ABRLD:No
Regulatory Exclusivity Expiration:Sep 18, 2016
Regulatory Exclusivity Use:PATENT CHALLENGE


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Dow
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Harvard Business School
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Teva

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