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Cerilliant
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Chubb
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Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091193

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NDA 091193 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 091193
Tradename:BACLOFEN
Applicant:Emerald Intl Ltd
Ingredient:baclofen
Patents:0
Therapeutic Class:Antispasticity Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091193
Medical Subject Heading (MeSH) Categories for 091193
Suppliers and Packaging for NDA: 091193
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BACLOFEN baclofen INJECTABLE;INTRATHECAL 091193 ANDA Sintetica S.A. 68055-346 N 68055-346-10
BACLOFEN baclofen INJECTABLE;INTRATHECAL 091193 ANDA Sintetica S.A. 68055-415 N 68055-415-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRATHECALStrength0.05MG/ML
Approval Date:May 3, 2016TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRATHECALStrength0.5MG/ML
Approval Date:May 3, 2016TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRATHECALStrength2MG/ML
Approval Date:May 3, 2016TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
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