Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208447
Company: GLAXOSMITHKLINE
Company: GLAXOSMITHKLINE
| 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 |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/03/2021 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208447s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208447Orig1s019, s020ltr.pdf | |
| 03/03/2021 | SUPPL-19 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208447s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208447Orig1s019, s020ltr.pdf | |
| 05/29/2020 | SUPPL-18 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208447Orig1s018ltr.pdf |
| 04/29/2020 | SUPPL-17 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208447s015s017lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208447Orig1s015, s017ltr.pdf | |
| 04/29/2020 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208447s015s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208447Orig1s015, s017ltr.pdf | |
| 10/23/2019 | SUPPL-14 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208447s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208447Orig1s014ltr.pdf | |
| 02/26/2020 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208447s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208447Orig1s012ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/03/2021 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208447s019s020lbl.pdf | |
| 03/03/2021 | SUPPL-19 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208447s019s020lbl.pdf | |
| 03/03/2021 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208447s019s020lbl.pdf | |
| 04/29/2020 | SUPPL-17 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208447s015s017lbledt.pdf | |
| 04/29/2020 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208447s015s017lbl.pdf | |
| 02/26/2020 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208447s012lbl.pdf | |
| 10/23/2019 | SUPPL-14 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208447s014lbl.pdf | |
| 03/27/2017 | ORIG-1 | Approval | Label (PDF) | httpS://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf |
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