NDA 208692 Review 1
Drug Name/Dosage Form Cabozantinib (S)-maleate Strength 20mg, 40 mg, 60 mg Route of Administration Oral Tablet Rx/OTC Dispensed Applicant Exelixis, Inc. US agent, if applicable
SUBMISSION(S) REVIEWED DOCUMENT DATE DISCIPLINE(S) AFFECTED
Quality Review Team
DISCIPLINE REVIEWER BRANCH/DIVISION Drug Substance Xiang Wang Drug Product Xiang Wang
Process Ying Zhang Microbiology N/A
Facility Laura Fontan Biopharmaceutics Fang Wu
Regulatory Business Process Manager
Rabiya Laiq Kristine Leahy
Application Technical Lead Xiao Chen Laboratory (OTR) N/A
ORA Lead Paul Perdue Environmental Assessment (EA) Raanan Bloom
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ROBYN S JORDON05/06/2016
Reference ID: 3927858
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