Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208558
Company: ASTRAZENECA
Company: ASTRAZENECA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LYNPARZA | OLAPARIB | 100MG | TABLET;ORAL | Prescription | None | Yes | No |
| LYNPARZA | OLAPARIB | 150MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 08/17/2017 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208558Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208558_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/12/2023 | SUPPL-29 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208558s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208558Orig1s029ltr.pdf | |
| 11/06/2023 | SUPPL-28 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208558s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208558Orig1s028ltr.pdf | |
| 08/26/2022 | SUPPL-26 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208558s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208558Orig1s026ltr.pdf | |
| 05/31/2023 | SUPPL-25 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208558s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208558Orig1s025ltr.pdf | |
| 10/27/2022 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208558s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208558Orig1s024ltr.pdf | |
| 03/11/2022 | SUPPL-23 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208558s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208558Orig1s023correctedltr.pdf | |
| 01/31/2022 | SUPPL-21 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208558s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208558Orig1s021ltr.pdf | |
| 03/11/2021 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208558s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208558Orig1s019,s020ltr.pdf | |
| 03/11/2021 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208558s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208558Orig1s019,s020ltr.pdf | |
| 11/02/2020 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208558s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208558Orig1s018ltr.pdf | |
| 12/07/2020 | SUPPL-16 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208558s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208558Orig1s016ltr.pdf | |
| 05/19/2020 | SUPPL-14 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208558s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208558Orig1s014ltr.pdf | |
| 05/08/2020 | SUPPL-13 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208558s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208558Orig1s013ltr.pdf | |
| 10/11/2019 | SUPPL-12 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208558Orig1s012ltr.pdf |
| 12/27/2019 | SUPPL-10 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208558Orig1s010lblrpl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208558Orig1s010ltr.pdf | |
| 07/01/2019 | SUPPL-9 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208558s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208558Orig1s009ltr.pdf | |
| 12/19/2018 | SUPPL-6 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208558s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208558Orig1s006Ltr.pdf | |
| 09/26/2018 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208558s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208558Orig1s005ltr.pdf | |
| 02/06/2018 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208558s002lbl.pdf | |
| 01/12/2018 | SUPPL-1 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208558s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208558Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/06/2023 | SUPPL-28 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208558s028lbl.pdf | |
| 09/12/2023 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208558s029lbl.pdf | |
| 09/12/2023 | SUPPL-29 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208558s029lbl.pdf | |
| 05/31/2023 | SUPPL-25 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208558s025lbl.pdf | |
| 10/27/2022 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208558s024lbl.pdf | |
| 08/26/2022 | SUPPL-26 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208558s026lbl.pdf | |
| 03/11/2022 | SUPPL-23 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208558s023lbl.pdf | |
| 01/31/2022 | SUPPL-21 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208558s021lbl.pdf | |
| 03/11/2021 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208558s019s020lbl.pdf | |
| 03/11/2021 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208558s019s020lbl.pdf | |
| 12/07/2020 | SUPPL-16 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208558s016lbl.pdf | |
| 11/02/2020 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208558s018lbl.pdf | |
| 05/19/2020 | SUPPL-14 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208558s014lbl.pdf | |
| 05/08/2020 | SUPPL-13 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208558s013lbl.pdf | |
| 12/27/2019 | SUPPL-10 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208558Orig1s010lblrpl.pdf | |
| 07/01/2019 | SUPPL-9 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208558s009lbl.pdf | |
| 12/19/2018 | SUPPL-6 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208558s006lbl.pdf | |
| 09/26/2018 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208558s005lbl.pdf | |
| 02/06/2018 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208558s002lbl.pdf | |
| 01/12/2018 | SUPPL-1 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208558s001lbl.pdf | |
| 08/17/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf |