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Last Updated: June 20, 2024

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 one supplier. Additional details are available on the GABLOFEN profile page.

The generic ingredient in GABLOFEN is baclofen. There are twenty-one drug master file entries for this compound. Sixty-four suppliers are listed for this compound. Additional details are available on the baclofen profile page.
Summary for 022462
Applicant:Piramal Critical
Formulation / Manufacturing:see details
Pharmacology for NDA: 022462
Mechanism of ActionGABA A Agonists
GABA B Agonists
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 Piramal Critical Care Inc 66794-151 66794-151-01 1 mL in 1 SYRINGE, GLASS (66794-151-01)
GABLOFEN baclofen INJECTABLE;INTRATHECAL 022462 NDA Piramal Critical Care Inc 66794-155 66794-155-01 20 mL in 1 SYRINGE, GLASS (66794-155-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRATHECALStrength0.05MG/ML
Approval Date:Nov 19, 2010TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRATHECALStrength0.5MG/ML
Approval Date:Nov 19, 2010TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRATHECALStrength2MG/ML
Approval Date:Nov 19, 2010TE:APRLD:Yes

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