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Chinese Patent Office

Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022462

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NDA 022462 describes GABLOFEN, which is a drug marketed by Piramal Critical and is included in one NDA. It is available from two suppliers. Additional details are available on the GABLOFEN profile page.

The generic ingredient in GABLOFEN is baclofen. There are eighteen 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 022462
Applicant:Piramal Critical
Therapeutic Class:Antispasticity Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 022462
Medical Subject Heading (MeSH) Categories for 022462
Suppliers and Packaging for NDA: 022462
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GABLOFEN baclofen INJECTABLE;INTRATHECAL 022462 NDA Mallinckrodt Inc (Brand Pharmaceuticals) 45945-155 N 45945-155-02
GABLOFEN baclofen INJECTABLE;INTRATHECAL 022462 NDA Mallinckrodt Inc (Brand Pharmaceuticals) 45945-155 N 45945-155-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRATHECALStrength0.05MG/ML
Approval Date:Nov 19, 2010TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRATHECALStrength0.5MG/ML
Approval Date:Nov 19, 2010TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRATHECALStrength2MG/ML
Approval Date:Nov 19, 2010TE:APRLD:No

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