trametinib Oral Tablet

Brand(s)
Mekinist
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Glaxosmithkline Llc (2014-01-10)
Oldest Current Product
2013-06-17
License(s)
NDA
RxNORM
ORAL TABLET\TRAMETINIB
FDAOB
ORAL\TABLET\TRAMETINIB DIMETHYL SULFOXIDE
SPL Active
ORAL\TABLET, FILM COATED\TRAMETINIB DIMETHYL SULFOXIDE
SPL Moiety
ORAL\TABLET, FILM COATED\TRAMETINIB

product(s) by strength(s)

trametinib 0.5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730849MekinistNDAGlaxosmithkline Llc2013-06-17TRAMETINIB DIMETHYL SULFOXIDEORALTABLET, FILM COATEDNDA204114aeaf0430-f8ad-4e72-9dbf-1954503c3410

trametinib 1 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730858MekinistNDAGlaxosmithkline Llc2013-06-17TRAMETINIB DIMETHYL SULFOXIDEORALTABLET, FILM COATEDNDA204114aeaf0430-f8ad-4e72-9dbf-1954503c3410

trametinib 2 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730848MekinistNDAGlaxosmithkline Llc2013-06-17TRAMETINIB DIMETHYL SULFOXIDEORALTABLET, FILM COATEDNDA204114aeaf0430-f8ad-4e72-9dbf-1954503c3410

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA204114MEKINISTNOVARTIS PHARMACEUTICALS CORP2013-05-29p8580304, SUBSTANCE
p7378423, SUBSTANCE
p8703781, MEKENIST IN COMBINATION WITH DABRAFENIB FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA, SUBSTANCE
p8835443, IN COMBINATION WITH DABRAFENIB FOR THE TREATMENT OF UNRESECTABLE OR METASTATIC MELANOMA./ TREATMENT OF UNRESECTABLE OR METASTATIC MELANOMA
ORPHAN DRUG EXCLUSIVITY [2020-05-29]
ORPHAN DRUG EXCLUSIVITY [2021-01-08]
NEW CHEMICAL ENTITY [2018-05-29]
TRAMETINIB [2017-01-08]
NDA204114_001, NDA204114_002, NDA204114_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA204114_001RXTRAMETINIB DIMETHYL SULFOXIDE (EQ 0.5MG NON-SOLVATED PARENT)ORALTABLETFalse2013-05-29MEKINIST
2NDA204114_002RXTRAMETINIB DIMETHYL SULFOXIDE (EQ 1MG NON-SOLVATED PARENT)ORALTABLETFalse2013-05-29MEKINIST
3NDA204114_003RXTRAMETINIB DIMETHYL SULFOXIDE (EQ 2MG NON-SOLVATED PARENT)ORALTABLETTrue2013-05-29MEKINIST

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p7378423 (view patent)2025-09-13NDA204114
2p8580304 (view patent)2032-01-28NDA204114
3p8703781 (view patent)2030-10-15NDA204114, NDA202806dabrafenib Oral Capsule
4p8835443 (view patent)2025-09-13NDA204114

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1aeaf0430-f8ad-4e72-9dbf-1954503c3410 (view SPL)These highlights do not include all the information needed to use MEKINIST safely and effectively. See full prescribing information for MEKINIST.MEKINIST (trametinib) tablets, for oral useInitial U.S. Approval: 2013prescriptionHuman PrescriptionGlaxosmithkline Llc2014-01-1010001730848, 001730849, 001730858

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