Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208855
Company: ELI LILLY AND CO
Company: ELI LILLY AND CO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VERZENIO | ABEMACICLIB | 50MG | TABLET;ORAL | Prescription | None | TBD | No |
VERZENIO | ABEMACICLIB | 100MG | TABLET;ORAL | Prescription | None | TBD | No |
VERZENIO | ABEMACICLIB | 150MG | TABLET;ORAL | Prescription | None | TBD | No |
VERZENIO | ABEMACICLIB | 200MG | TABLET;ORAL | Prescription | None | 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 |
---|---|---|---|---|---|---|---|
02/26/2018 | ORIG-1 | Approval | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208855s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208855Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208855Orig1s000TOC.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/26/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208855s000lbl.pdf |