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Serving hundreds of leading biopharmaceutical companies globally:

US Army
US Department of Justice
Fish and Richardson

Generated: June 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 073092

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NDA 073092 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 073092
Applicant:Watson Labs
Therapeutic Class:Antispasticity Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 073092
Medical Subject Heading (MeSH) Categories for 073092
Suppliers and Packaging for NDA: 073092
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BACLOFEN baclofen TABLET;ORAL 073092 ANDA Med Health Pharma, LLC 51138-007 E 51138-007-30
BACLOFEN baclofen TABLET;ORAL 073092 ANDA Med Health Pharma, LLC 51138-008 E 51138-008-30

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG
Approval Date:Jan 28, 1994TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
US Army
Boehringer Ingelheim

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