panobinostat Oral Capsule

Brand(s)
Farydak
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Novartis Pharmaceuticals Corporation (2015-02-23)
Oldest Current Product
2015-02-23
License(s)
NDA
RxNORM
ORAL CAPSULE\PANOBINOSTAT
FDAOB
ORAL\CAPSULE\PANOBINOSTAT LACTATE
SPL Active
ORAL\CAPSULE\PANOBINOSTAT LACTATE
SPL Moiety
ORAL\CAPSULE\PANOBINOSTAT

product(s) by strength(s)

panobinostat 10 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780650FarydakNDANovartis Pharmaceuticals Corporation2015-02-23PANOBINOSTAT LACTATEORALCAPSULENDA2053537774972a-eeaa-4b9a-9e56-3fc1b968e86a

panobinostat 15 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780651FarydakNDANovartis Pharmaceuticals Corporation2015-02-23PANOBINOSTAT LACTATEORALCAPSULENDA2053537774972a-eeaa-4b9a-9e56-3fc1b968e86a

panobinostat 20 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780652FarydakNDANovartis Pharmaceuticals Corporation2015-02-23PANOBINOSTAT LACTATEORALCAPSULENDA2053537774972a-eeaa-4b9a-9e56-3fc1b968e86a

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA205353FARYDAKNOVARTIS PHARMACEUTICALS CORP2015-02-23p7989494, SUBSTANCE
p6552065, SUBSTANCE
p6833384, TREATMENT OF MULTIPLE MYELOMA, SUBSTANCE
p8883842, TREATMENT OF MULTIPLE MYELOMA
p7067551, TREATMENT OF MULTIPLE MYELOMA
ORPHAN DRUG EXCLUSIVITY [2022-02-23]
NEW CHEMICAL ENTITY [2020-02-23]
NDA205353_001, NDA205353_002, NDA205353_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA205353_001RXPANOBINOSTAT LACTATE (EQ 10MG BASE)ORALCAPSULEFalse2015-02-23FARYDAK
2NDA205353_002RXPANOBINOSTAT LACTATE (EQ 15MG BASE)ORALCAPSULEFalse2015-02-23FARYDAK
3NDA205353_003RXPANOBINOSTAT LACTATE (EQ 20MG BASE)ORALCAPSULETrue2015-02-23FARYDAK

patent(s)

#idexpiration dateapplication(s)
1p6552065 (view patent)2021-08-31NDA205353
2p6833384 (view patent)2021-09-30NDA205353
3p7067551 (view patent)2021-08-31NDA205353
4p7989494 (view patent)2028-01-17NDA205353
5p8883842 (view patent)2028-06-13NDA205353

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
17774972a-eeaa-4b9a-9e56-3fc1b968e86a (view SPL)These highlights do not include all the information needed to use FARYDAK safely and effectively. See full prescribing information for FARYDAK. FARYDAK (panobinostat) capsules, for oral use Initial U.S. Approval: 2015prescriptionHuman PrescriptionNovartis Pharmaceuticals Corporation2015-02-232000780650, 000780651, 000780652

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