cabozantinib Oral Capsule

Brand(s)
Cometriq
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Exelixis, Inc. (2012-12-04)
Oldest Current Product
2012-11-29
License(s)
NDA
RxNORM
ORAL CAPSULE\CABOZANTINIB
FDAOB
ORAL\CAPSULE\CABOZANTINIB S-MALATE
SPL Active
ORAL\CAPSULE\CABOZANTINIB S-MALATE
SPL Moiety
ORAL\CAPSULE\CABOZANTINIB

product(s) by strength(s)

cabozantinib 20 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1423880012CometriqNDAExelixis, Inc.2012-11-29CABOZANTINIB S-MALATEORALCAPSULENDA2037561a0c3bea-c87b-4d25-bb44-5f0174da6b34
2423880014CometriqNDAExelixis, Inc.2012-11-29CABOZANTINIB S-MALATEORALCAPSULENDA2037561a0c3bea-c87b-4d25-bb44-5f0174da6b34

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA203756COMETRIQEXELIXIS INC2012-11-29p7579473, SUBSTANCE
p8877776, METHOD OF TREATING MEDULLARY THYROID CANCER, SUBSTANCE
ORPHAN DRUG EXCLUSIVITY [2019-11-29]
NEW CHEMICAL ENTITY [2017-11-29]
NDA203756_001, NDA203756_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203756_001RXCABOZANTINIB S-MALATE (EQ 20MG BASE)ORALCAPSULEFalse2012-11-29COMETRIQ
2NDA203756_002RXCABOZANTINIB S-MALATE (EQ 80MG BASE)ORALCAPSULETrue2012-11-29COMETRIQ

patent(s)

#idexpiration dateapplication(s)
1p7579473 (view patent)2024-09-24NDA203756
2p8877776 (view patent)2030-10-08NDA203756

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11a0c3bea-c87b-4d25-bb44-5f0174da6b34 (view SPL)These highlights do not include all the information needed to use COMETRIQ safely and effectively. See full prescribing information for COMETRIQ.COMETRIQ (cabozantinib) capsules, for oral useInitial U.S. Approval: 2012prescriptionHuman PrescriptionExelixis, Inc.MANUFACTURE2012-12-042423880012, 423880014, 423880011, 423880013

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII