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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203993

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NDA 203993 describes ONFI, which is a drug marketed by Lundbeck Pharms Llc and is included in two NDAs. It is available from one supplier. Additional details are available on the ONFI profile page.

The generic ingredient in ONFI is clobazam. There are ten drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the clobazam profile page.
Summary for 203993
Tradename:ONFI
Applicant:Lundbeck Pharms Llc
Ingredient:clobazam
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203993
Suppliers and Packaging for NDA: 203993
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONFI clobazam SUSPENSION;ORAL 203993 NDA Lundbeck Pharmaceuticals LLC 67386-313 67386-313-21 1 BOTTLE in 1 CARTON (67386-313-21) > 120 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength2.5MG/ML
Approval Date:Dec 14, 2012TE:ABRLD:Yes

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