Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208447
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
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
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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