Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 206038
Company: VERTEX PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ORKAMBI IVACAFTOR; LUMACAFTOR 125MG;200MG TABLET;ORAL Prescription None Yes Yes
ORKAMBI IVACAFTOR; LUMACAFTOR 125MG;100MG 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
07/02/2015 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206038Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206038Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/0206038Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/0206038Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/06/2016 SUPPL-6 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206038Orig1s006ltr.pdf
09/28/2016 SUPPL-5 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206038s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206038Orig1s005ltr.pdf
08/05/2016 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/06/2016 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/18/2016 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/18/2016 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206038s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206038Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/28/2016 SUPPL-5 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206038s005lbl.pdf
05/18/2016 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206038s001lbl.pdf
07/02/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206038Orig1s000lbl.pdf

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