U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 208558
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 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
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
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
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
Back to Top