Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 217581
Company: PF PRISM CV
Company: PF PRISM CV
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
XALKORI | CRIZOTINIB | 20MG | CAPSULE, PELLETS;ORAL | Prescription | None | Yes | No |
XALKORI | CRIZOTINIB | 50MG | CAPSULE, PELLETS;ORAL | Prescription | None | Yes | No |
XALKORI | CRIZOTINIB | 150MG | CAPSULE, PELLETS;ORAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
09/07/2023 | ORIG-1 | Approval | STANDARD; Orphan |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217581s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217581Orig1s000ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/07/2023 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217581s000lbl.pdf |