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Drugs@FDA: FDA-Approved Drugs

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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;150MG, 100MG TABLET;ORAL Prescription None Yes Yes
SYMDEKO (COPACKAGED) IVACAFTOR; IVACAFTOR, TEZACAFTOR 75MG;75MG, 50MG TABLET;ORAL Prescription None Yes 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 and Type 4 - New Combination 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
08/03/2023 SUPPL-11 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210491s011lbl.pdf
12/21/2020 SUPPL-7 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210491s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210491Orig1s007ltr.pdf
12/27/2019 SUPPL-5 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210491s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210491Orig1s005ltr.pdf
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
08/03/2023 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210491s011lbl.pdf
12/21/2020 SUPPL-7 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210491s007lbl.pdf
12/27/2019 SUPPL-5 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210491s005lbl.pdf
12/27/2019 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210491s005lbl.pdf
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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