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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

Tradename:
COTELLIC
Applicant:
Genentech Inc
Ingredient:
cobimetinib fumarate
Patents:2

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
COTELLIC
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?
Patented Use:METHOD OF USING COBIMETINIB FOR THE TREATMENT OF MELANOMA
Regulatory Exclusivity Expiration:Nov 10, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY


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