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Fish and Richardson
Farmers Insurance
US Department of Justice

Generated: June 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077241

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NDA 077241 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-one 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-five suppliers are listed for this compound. Additional details are available on the baclofen profile page.
Summary for 077241
Applicant:Lannett Co Inc
Therapeutic Class:Antispasticity Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 077241
Medical Subject Heading (MeSH) Categories for 077241
Suppliers and Packaging for NDA: 077241
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BACLOFEN baclofen TABLET;ORAL 077241 ANDA Lannett Company, Inc. 0527-1337 N 0527-1337-01
BACLOFEN baclofen TABLET;ORAL 077241 ANDA Lannett Company, Inc. 0527-1337 N 0527-1337-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Dec 20, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jul 6, 2007TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
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