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Details for New Drug Application (NDA): 206192

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NDA 206192 describes COTELLIC, which is a drug marketed by Genentech Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the COTELLIC profile page.

The generic ingredient in COTELLIC is cobimetinib fumarate. One supplier is listed for this compound. Additional details are available on the cobimetinib fumarate profile page.

Summary for NDA: 206192


Pharmacology for NDA: 206192

Mechanism of ActionKinase Inhibitors

Suppliers and Packaging for NDA: 206192

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
cobimetinib fumarate
TABLET;ORAL 206192 NDA Genentech, Inc. 50242-717 50242-717-01 63 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50242-717-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Nov 10, 2015TE:RLD:Yes
Patent:7,803,839Patent Expiration:Feb 1, 2027Product Flag?YSubstance Flag?YDelist Request?
Patent:8,362,002Patent Expiration:Oct 5, 2026Product Flag?Substance Flag?Delist Request?
Regulatory Exclusivity Expiration:Nov 10, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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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.