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Details for New Drug Application (NDA): 022462

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NDA 022462 describes GABLOFEN, which is a drug marketed by Mallinckrodt Inc 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 seventeen drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the baclofen profile page.

Summary for NDA: 022462

Mallinckrodt Inc
Therapeutic Class:Antispasticity Agents

Pharmacology for NDA: 022462

Suppliers and Packaging for NDA: 022462

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;INTRATHECAL 022462 NDA Mallinckrodt Inc (Brand Pharmaceuticals) 45945-151 45945-151-01 1 mL in 1 SYRINGE, GLASS (45945-151-01)
INJECTABLE;INTRATHECAL 022462 NDA Mallinckrodt Inc (Brand Pharmaceuticals) 45945-155 45945-155-01 20 mL in 1 SYRINGE, GLASS (45945-155-01)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

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