Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 204114
Company: NOVARTIS PHARMS CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MEKINIST TRAMETINIB DIMETHYL SULFOXIDE EQ 0.5MG TABLET;ORAL Prescription None Yes No
MEKINIST TRAMETINIB DIMETHYL SULFOXIDE EQ 1MG TABLET;ORAL Discontinued None Yes No
MEKINIST TRAMETINIB DIMETHYL SULFOXIDE EQ 2MG TABLET;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/29/2013 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204114s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204114Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204114Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204114Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/24/2017 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204114s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204114Orig1s006ltr.pdf
06/22/2017 SUPPL-5 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204114s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204114Orig1s005ltr.pdf
11/20/2015 SUPPL-4 Efficacy-Accelerated Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204114s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204114Orig1s004ltr.pdf
09/26/2014 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/13/2014 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/08/2014 SUPPL-1 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204114s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204114Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/22/2017 SUPPL-5 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204114s005lbl.pdf
02/24/2017 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204114s006lbl.pdf
11/20/2015 SUPPL-4 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204114s004lbl.pdf
01/08/2014 SUPPL-1 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204114s001lbl.pdf
05/29/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204114s000lbl.pdf

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