Drugs@FDA: FDA Approved Drug Products
New Drug Application (NDA): 208447
Company: TESARO INC
Company: TESARO INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZEJULA | NIRAPARIB TOSYLATE | EQ 100MG BASE | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 03/27/2017 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
httpS://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208447Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208447_zejula_toc.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/27/2017 | ORIG-1 | Approval | Label (PDF) | httpS://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf |
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