Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 208434
Company: HOFFMANN-LA ROCHE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALECENSA ALECTINIB HYDROCHLORIDE EQ 150MG BASE CAPSULE;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
12/11/2015 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208434s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208434Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208434Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/04/2016 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208434s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208434Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/04/2016 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208434s001lbl.pdf
12/11/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208434s000lbl.pdf

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