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Serving 500+ biopharmaceutical companies globally:

Moodys
Dow
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Generated: August 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 072234

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NDA 072234 describes BACLOFEN, which is a drug marketed by Northstar Hlthcare, Mylan, Watson Labs, Ivax Sub Teva Pharms, Mylan Pharms Inc, Lannett, Teva, Vintage Pharms, Usl Pharma, Sun Pharm Inds Inc, Impax Labs, Caraco, Oxford Pharms, and Emerald Intl Ltd, 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 NDA: 072234

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

Pharmacology for NDA: 072234

Suppliers and Packaging for NDA: 072234

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BACLOFEN
baclofen
TABLET;ORAL 072234 ANDA Teva Pharmaceuticals USA, Inc. 0172-4096 0172-4096-60 100 TABLET in 1 BOTTLE (0172-4096-60)
BACLOFEN
baclofen
TABLET;ORAL 072234 ANDA Teva Pharmaceuticals USA, Inc. 0172-4096 0172-4096-80 1000 TABLET in 1 BOTTLE (0172-4096-80)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jul 21, 1988TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

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Queensland Health
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