Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 212273
Company: VERTEX PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIKAFTA ELEXACAFTOR, TEZACAFTOR, IVACAFTOR; IVACAFTOR 100MG, 75MG, 50MG; 150MG TABLET; ORAL Prescription TBD TBD 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
10/21/2019 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212273s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212273Orig1s000ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/21/2019 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212273s000lbl.pdf

TRIKAFTA

There are no Therapeutic Equivalents.

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