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Details for New Drug Application (NDA): 208692

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NDA 208692 describes CABOMETYX, which is a drug marketed by Exelixis Inc and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the CABOMETYX profile page.

The generic ingredient in CABOMETYX is cabozantinib s-malate. One supplier is listed for this compound. Additional details are available on the cabozantinib s-malate profile page.

Summary for NDA: 208692

Exelixis Inc
cabozantinib s-malate

Pharmacology for NDA: 208692

Mechanism of ActionProtein Kinase Inhibitors

Suppliers and Packaging for NDA: 208692

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
cabozantinib s-malate
TABLET;ORAL 208692 NDA Exelixis, Inc. 42388-023 42388-023-26 30 TABLET in 1 BOTTLE (42388-023-26)
cabozantinib s-malate
TABLET;ORAL 208692 NDA Exelixis, Inc. 42388-024 42388-024-26 30 TABLET in 1 BOTTLE (42388-024-26)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Apr 25, 2016TE:RLD:No
Patent:7,579,473Patent Expiration:Sep 24, 2024Product Flag?YSubstance Flag?YDelist Request?
Patent:8,877,776Patent Expiration:Oct 8, 2030Product Flag?YSubstance Flag?YDelist Request?
Regulatory Exclusivity Expiration:Nov 29, 2017
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.