.

Deeper Knowledge, Faster

  • Anticipate your formulary budget
  • Find suppliers and generic API sources
  • Predict branded drug patent expiration

► See Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving 500+ biopharmaceutical companies globally:

Express Scripts
Daiichi Sankyo
Citi
Queensland Health
McKinsey
US Department of Justice
Argus Health
Dow
Merck
QuintilesIMS

Generated: June 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202067

« 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 nine 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 NDA: 202067

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG
Approval Date:Oct 21, 2011TE:RLD:No
Regulatory Exclusivity Expiration:Oct 21, 2016
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Oct 21, 2018
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Oct 21, 2011TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 21, 2016
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY


Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
Teva
Medtronic
QuintilesIMS
Federal Trade Commission
Fish and Richardson
Queensland Health
Chubb
McKinsey
Mallinckrodt

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 verifification 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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot