.

Make Better Decisions

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Drug patents in 130+ countries

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Citi
Johnson and Johnson
US Department of Justice
Federal Trade Commission
Fuji
Colorcon
Boehringer Ingelheim
Queensland Health
Chubb

Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201509

« Back to Dashboard

NDA 201509 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 201509

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

Pharmacology for NDA: 201509

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

Suppliers and Packaging for NDA: 201509

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLPIDEM TARTRATE zolpidem tartrate TABLET;SUBLINGUAL 201509 ANDA Par Pharmaceutical, Inc. 49884-903 49884-903-52 10 TABLET in 1 BLISTER PACK (49884-903-52)
ZOLPIDEM TARTRATE zolpidem tartrate TABLET;SUBLINGUAL 201509 ANDA Par Pharmaceutical, Inc. 49884-903 49884-903-55 30 TABLET in 1 CARTON (49884-903-55)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrength5MG
Approval Date:Aug 1, 2016TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrength10MG
Approval Date:Aug 1, 2016TE:ABRLD:No


Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Fuji
Baxter
Teva
Harvard Business School
McKesson
Daiichi Sankyo
Queensland Health
Johnson and Johnson
McKinsey
Cantor Fitzgerald

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot