Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 210491
Company: VERTEX PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SYMDEKO (COPACKAGED) IVACAFTOR; IVACAFTOR, TEZACAFTOR 150MG,N/A;150MG, 100MG TABLET, TABLET;ORAL Prescription None Yes Yes
SYMDEKO (COPACKAGED) IVACAFTOR;IVACAFTOR;TEZACAFTOR 75MG;75MG;50MG TABLET;ORAL Prescription None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/12/2018 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210491lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210491Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210491Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/21/2019 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210491s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210491Orig1s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/21/2019 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210491s003lbl.pdf
02/12/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210491lbl.pdf

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