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Serving leading biopharmaceutical companies globally:

Covington
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Julphar
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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078055

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NDA 078055 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 078055

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Sedatives/Hypnotics
Formulation / Manufacturing:see details

Pharmacology for NDA: 078055

Ingredient-typePyridines
Mechanism of ActionGABA A Agonists
Physiological EffectCentral Nervous System Depression

Suppliers and Packaging for NDA: 078055

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLPIDEM TARTRATE zolpidem tartrate TABLET;ORAL 078055 ANDA Ranbaxy Pharmaceuticals Inc. 63304-159 63304-159-03 10 TABLET, FILM COATED in 1 BOTTLE (63304-159-03)
ZOLPIDEM TARTRATE zolpidem tartrate TABLET;ORAL 078055 ANDA Ranbaxy Pharmaceuticals Inc. 63304-159 63304-159-10 1000 TABLET, FILM COATED in 1 BOTTLE (63304-159-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Apr 23, 2007TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Apr 23, 2007TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Fuji
Fish and Richardson
Mallinckrodt
Daiichi Sankyo
Novartis
Julphar
Deloitte
Baxter
US Department of Justice
AstraZeneca

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 verifification 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.

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