.

Deeper Knowledge, Faster

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents

► See Plans & Pricing

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

Serving 500+ biopharmaceutical companies globally:

Julphar
UBS
Merck
Farmers Insurance
Johnson and Johnson
Deloitte
Fuji
Colorcon
Fish and Richardson
Harvard Business School

Generated: July 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078491

« Back to Dashboard
NDA 078491 describes ALPRAZOLAM, which is a drug marketed by Sandoz, West-ward Pharms Int, Roxane, Mylan, Ani Pharms Inc, Natco Pharma Ltd, Apotex Inc, Vintage Pharms, Actavis Elizabeth, Aurobindo Pharma Ltd, Mylan Pharms Inc, Watson Labs, Impax Labs, Anchen Pharms, Dava Intl Inc, Sandoz Inc, Sun Pharma Global, Amneal Pharms Ny, Par Pharm, Heritage Pharms Inc, Vintage, Ivax Sub Teva Pharms, Impax Labs Inc, and Actavis Labs Fl Inc, and is included in thirty-five NDAs. It is available from fifty-one suppliers. Additional details are available on the ALPRAZOLAM profile page.

The generic ingredient in ALPRAZOLAM is alprazolam. There are fifteen drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the alprazolam profile page.

Summary for NDA: 078491

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 078491

Ingredient-typeBenzodiazepines

Suppliers and Packaging for NDA: 078491

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALPRAZOLAM
alprazolam
TABLET;ORAL 078491 ANDA Medsource Pharmaceuticals 45865-424 45865-424-30 30 TABLET in 1 BOTTLE, PLASTIC (45865-424-30)
ALPRAZOLAM
alprazolam
TABLET;ORAL 078491 ANDA Medsource Pharmaceuticals 45865-424 45865-424-60 60 TABLET in 1 BOTTLE, PLASTIC (45865-424-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG
Approval Date:Sep 25, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Sep 25, 2008TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Sep 25, 2008TE:ABRLD:No


Complete Access Available with Subscription
« Back to Dashboard

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

Serving 500+ biopharmaceutical companies globally:

US Department of Justice
Johnson and Johnson
Boehringer Ingelheim
AstraZeneca
Harvard Business School
McKesson
Express Scripts
Accenture
Mallinckrodt
Healthtrust

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 Heap | Mobile and Web Analytics

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot