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Chinese Patent Office
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Merck
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Fuji
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Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074584

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NDA 074584 describes BACLOFEN, which is a drug marketed by Emerald Intl Ltd, Mylan Labs Ltd, Impax Labs, Ivax Sub Teva Pharms, Lannett Co Inc, Mylan, Mylan Pharms Inc, Northstar Hlthcare, Oxford Pharms, Rubicon Res Pvt Ltd, Sun Pharm Inds Inc, Teva, Usl Pharma, Vintage Pharms, and Watson Labs, and is included in twenty-five NDAs. It is available from forty-two suppliers. Additional details are available on the BACLOFEN profile page.

The generic ingredient in BACLOFEN is baclofen. There are nineteen drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the baclofen profile page.
Summary for 074584
Tradename:BACLOFEN
Applicant:Usl Pharma
Ingredient:baclofen
Patents:0
Therapeutic Class:Antispasticity Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 074584
Medical Subject Heading (MeSH) Categories for 074584
Suppliers and Packaging for NDA: 074584
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BACLOFEN baclofen TABLET;ORAL 074584 ANDA Upsher-Smith Laboratories, Inc. 0832-1024 N 0832-1024-00
BACLOFEN baclofen TABLET;ORAL 074584 ANDA Upsher-Smith Laboratories, Inc. 0832-1024 N 0832-1024-09

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Aug 19, 1996TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Aug 19, 1996TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
US Army
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Harvard Business School
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