.

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:

Accenture
Deloitte
Merck
Argus Health
Chubb
US Department of Justice
Teva
Healthtrust
Federal Trade Commission
Cantor Fitzgerald

Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090334

« Back to Dashboard

NDA 090334 describes BACLOFEN, which is a drug marketed by Emerald Intl Ltd, Caraco, Impax Labs, Ivax Sub Teva Pharms, Lannett, Mylan, Mylan Pharms Inc, Northstar Hlthcare, Oxford Pharms, Sun Pharm Inds Inc, Teva, Usl Pharma, Vintage Pharms, and Watson Labs, and is included in twenty-four NDAs. It is available from forty-three suppliers. Additional details are available on the BACLOFEN profile page.

The generic ingredient in BACLOFEN is baclofen. There are eighteen drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the baclofen profile page.

Summary for 090334

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antispasticity Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 090334

Medical Subject Heading (MeSH) Categories for 090334

Suppliers and Packaging for NDA: 090334

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BACLOFEN baclofen TABLET;ORAL 090334 ANDA Mylan Pharmaceuticals Inc. 0378-3023 0378-3023-10 1000 TABLET in 1 BOTTLE, PLASTIC (0378-3023-10)
BACLOFEN baclofen TABLET;ORAL 090334 ANDA Mylan Pharmaceuticals Inc. 0378-3023 0378-3023-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-3023-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Feb 18, 2010TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Feb 18, 2010TE: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:

Teva
Fish and Richardson
Cerilliant
AstraZeneca
Citi
US Department of Justice
Mallinckrodt
Express Scripts
Argus Health
Colorcon

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