dabrafenib Oral Capsule

Brand(s)
Tafinlar
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Glaxosmithkline Llc (2014-01-13)
Oldest Current Product
2013-06-10
License(s)
NDA
RxNORM
ORAL CAPSULE\DABRAFENIB
FDAOB
ORAL\CAPSULE\DABRAFENIB MESYLATE
SPL Active
ORAL\CAPSULE\DABRAFENIB MESYLATE
SPL Moiety
ORAL\CAPSULE\DABRAFENIB

product(s) by strength(s)

dabrafenib 50 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730846TafinlarNDAGlaxosmithkline Llc2013-06-10DABRAFENIB MESYLATEORALCAPSULENDA202806803beaaa-33f9-48cc-9a95-c2e887e095b4

dabrafenib 75 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730847TafinlarNDAGlaxosmithkline Llc2013-06-10DABRAFENIB MESYLATEORALCAPSULENDA202806803beaaa-33f9-48cc-9a95-c2e887e095b4

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA202806TAFINLARNOVARTIS PHARMACEUTICALS CORP2013-05-29p8415345, TREATMENT OF MELANOMA, SUBSTANCE
p7994185, TREATMENT OF MELANOMA, SUBSTANCE
p8703781, TAFINLAR IN COMBINATION WITH TRAMETINIB FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA, SUBSTANCE
TRAMETINIB [2017-01-08]
NEW CHEMICAL ENTITY [2018-05-29]
ORPHAN DRUG EXCLUSIVITY [2020-05-29]
ORPHAN DRUG EXCLUSIVITY [2021-01-09]
NDA202806_001, NDA202806_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202806_001RXDABRAFENIB MESYLATE (EQ 50MG BASE)ORALCAPSULEFalse2013-05-29TAFINLAR
2NDA202806_002RXDABRAFENIB MESYLATE (EQ 75MG BASE)ORALCAPSULETrue2013-05-29TAFINLAR

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p7994185 (view patent)2030-01-20NDA202806
2p8415345 (view patent)2030-01-20NDA202806
3p8703781 (view patent)2030-10-15NDA202806, NDA204114trametinib Oral Tablet

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1803beaaa-33f9-48cc-9a95-c2e887e095b4 (view SPL)These highlights do not include all the information needed to use TAFINLAR safely and effectively. See full prescribing information for TAFINLAR. TAFINLAR (dabrafenib) capsules, for oral useInitial U.S. Approval: 2013prescriptionHuman PrescriptionGlaxosmithkline Llc2014-01-139001730846, 001730847

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