sonidegib Oral Capsule

Brand(s)
Odomzo
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Novartis Pharmaceuticals Corporation (2015-07-24)
Oldest Current Product
2015-07-24
License(s)
NDA
RxNORM
ORAL CAPSULE\SONIDEGIB
FDAOB
ORAL\CAPSULE\SONIDEGIB PHOSPHATE
SPL Active
ORAL\CAPSULE\SONIDEGIB PHOSPHATE
SPL Moiety
ORAL\CAPSULE\SONIDEGIB

product(s) by strength(s)

sonidegib 200 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780645OdomzoNDANovartis Pharmaceuticals Corporation2015-07-24SONIDEGIB PHOSPHATEORALCAPSULENDA20526677bd079b-7168-454a-ac38-963f8ba34324

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA205266ODOMZONOVARTIS PHARMACEUTICALS CORP2015-07-24p8178563, TREATMENT OF BASAL CELL CARCINOMA
p8063043, SUBSTANCE
NEW CHEMICAL ENTITY [2020-07-24]NDA205266_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA205266_001RXSONIDEGIB PHOSPHATE (EQ 200MG BASE)ORALCAPSULETrue2015-07-24ODOMZO

patent(s)

#idexpiration dateapplication(s)
1p8063043 (view patent)2029-09-15NDA205266
2p8178563 (view patent)2029-02-06NDA205266

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
177bd079b-7168-454a-ac38-963f8ba34324 (view SPL)These highlights do not include all the information needed to use ODOMZO safely and effectively. See full prescribing information for ODOMZO. ODOMZO (sonidegib) capsules, for oral use Initial U.S. Approval: 2015prescriptionHuman PrescriptionNovartis Pharmaceuticals Corporation2015-07-241000780645

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