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Serving leading biopharmaceutical companies globally:

Queensland Health

Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 072825

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NDA 072825 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 072825

Therapeutic Class:Antispasticity Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 072825

Medical Subject Heading (MeSH) Categories for 072825

Suppliers and Packaging for NDA: 072825

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BACLOFEN baclofen TABLET;ORAL 072825 ANDA Rebel Distributors Corp. 21695-015 21695-015-90 90 BOTTLE in 1 BOTTLE (21695-015-90) > 60 TABLET in 1 BOTTLE (21695-015-60)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength20MG
Approval Date:Sep 18, 1991TE:RLD:No

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Serving leading biopharmaceutical companies globally:

US Department of Justice
Cantor Fitzgerald
Fish and Richardson
Daiichi Sankyo

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