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Generated: November 15, 2018

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Details for New Drug Application (NDA): 202067

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NDA 202067 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. One supplier is listed for this compound. Additional details are available on the clobazam profile page.
Summary for 202067
Tradename:ONFI
Applicant:Lundbeck Pharms Llc
Ingredient:clobazam
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202067
Ingredient-typeBenzodiazepines
Mechanism of ActionCytochrome P450 2D6 Inhibitors
Suppliers and Packaging for NDA: 202067
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONFI clobazam TABLET;ORAL 202067 NDA Lundbeck Pharmaceuticals LLC 67386-314 67386-314-01 1 BOTTLE in 1 CARTON (67386-314-01) > 100 TABLET in 1 BOTTLE
ONFI clobazam TABLET;ORAL 202067 NDA Lundbeck Pharmaceuticals LLC 67386-315 67386-315-01 1 BOTTLE in 1 CARTON (67386-315-01) > 100 TABLET in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG
Approval Date:Oct 21, 2011TE:RLD:No
Regulatory Exclusivity Expiration:Oct 21, 2018
Regulatory Exclusivity Use:ADJUNCTIVE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME IN PATIENTS 2 YEARS OF AGE OR OLDER

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Oct 21, 2011TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 21, 2018
Regulatory Exclusivity Use:ADJUNCTIVE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME IN PATIENTS 2 YEARS OF AGE OR OLDER

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Oct 21, 2011TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 21, 2018
Regulatory Exclusivity Use:ADJUNCTIVE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME IN PATIENTS 2 YEARS OF AGE OR OLDER

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