palbociclib Oral Capsule

Brand(s)
Ibrance
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pfizer Labs (2015-01-23)
Oldest Current Product
2015-02-03
License(s)
NDA
RxNORM
ORAL CAPSULE\PALBOCICLIB
FDAOB
ORAL\CAPSULE\PALBOCICLIB
SPL Active
ORAL\CAPSULE\PALBOCICLIB
SPL Moiety
ORAL\CAPSULE\PALBOCICLIB

product(s) by strength(s)

palbociclib 100 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000690188IbranceNDAPfizer Labs2015-02-03PALBOCICLIBORALCAPSULENDA207103e0e6412f-50b4-4fd4-9364-62818d121a07

palbociclib 125 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1635390189IbranceNDAU.S. Pharmaceuticals2015-02-03PALBOCICLIBORALCAPSULENDA20710386718885-da44-4d3d-b3ca-06cbcedcffd8

palbociclib 75 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000690187IbranceNDAPfizer Labs2015-02-03PALBOCICLIBORALCAPSULENDA207103e0e6412f-50b4-4fd4-9364-62818d121a07

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA207103IBRANCEPFIZER INC2015-02-03p6936612, SUBSTANCE
p7208489, SUBSTANCE
p7456168, TREATMENT OF ER-POSITIVE
NEW CHEMICAL ENTITY [2020-02-03]NDA207103_001, NDA207103_002, NDA207103_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA207103_001RXPALBOCICLIB (75MG)ORALCAPSULEFalse2015-02-03IBRANCE
2NDA207103_002RXPALBOCICLIB (100MG)ORALCAPSULEFalse2015-02-03IBRANCE
3NDA207103_003RXPALBOCICLIB (125MG)ORALCAPSULETrue2015-02-03IBRANCE

patent(s)

#idexpiration dateapplication(s)
1p6936612 (view patent)2023-01-22NDA207103
2p7208489 (view patent)2023-01-16NDA207103
3p7456168 (view patent)2023-01-16NDA207103

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
186718885-da44-4d3d-b3ca-06cbcedcffd8 (view SPL)These highlights do not include all the information needed to use IBRANCE safely and effectively. See full prescribing information for IBRANCE. IBRANCE (palbociclib) capsules, for oral useInitial U.S. Approval: 2015prescriptionHuman PrescriptionU.S. PharmaceuticalsANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-02-041635390189
2e0e6412f-50b4-4fd4-9364-62818d121a07 (view SPL)These highlights do not include all the information needed to use IBRANCE safely and effectively. See full prescribing information for IBRANCE. IBRANCE (palbociclib) capsules, for oral useInitial U.S. Approval: 2015prescriptionHuman PrescriptionPfizer LabsANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-01-231000690187, 000690188, 000690189

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