U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 211358
Company: VERTEX PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ORKAMBI IVACAFTOR; LUMACAFTOR 125MG/PACKET;100MG/PACKET GRANULE;ORAL Prescription None Yes No
ORKAMBI IVACAFTOR; LUMACAFTOR 188MG/PACKET;150MG/PACKET GRANULE;ORAL Prescription None Yes Yes
ORKAMBI IVACAFTOR; LUMACAFTOR 94MG/PACKET;75MG/PACKET GRANULE;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
08/07/2018 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211358s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/211358Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211358Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/02/2022 SUPPL-4 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211358s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211358Orig1s004ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/02/2022 SUPPL-4 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211358s004lbl.pdf
08/07/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211358s000lbl.pdf
Back to Top