FDA Approval for TRIKAFTA issued to VERTEX PHARMS INC
Company: VERTEX PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRIKAFTA | ELEXACAFTOR;TEZACAFTOR;IVACAFTOR;IVACAFTOR | 50MG;25MG;37.5MG;75MG | GRANULES;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 |
---|---|---|---|---|---|---|---|
04/26/2023 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY; Orphan |
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