➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Medtronic
Moodys
Colorcon
Johnson and Johnson
AstraZeneca
Dow

Last Updated: July 13, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202067


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

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. Twenty suppliers are 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
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 **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Oct 21, 2011TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Oct 21, 2011TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Oct 21, 2011TE:ABRLD:Yes

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Moodys
Express Scripts
Colorcon
Johnson and Johnson
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.