Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 213973
Company: DECIPHERA PHARMS
Company: DECIPHERA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
QINLOCK | RIPRETINIB | 50MG | 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 |
---|---|---|---|---|---|---|---|
05/15/2020 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213973s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213973Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213973Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/26/2023 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213973s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213973Orig1s007ltr.pdf | |
12/29/2022 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213973s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213973Orig1s004ltr.pdf | |
09/15/2022 | SUPPL-3 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213973s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213973Orig1s003ltr.pdf | |
06/17/2021 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213973s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213973Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/26/2023 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213973s007lbl.pdf | |
12/29/2022 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213973s004lbl.pdf | |
09/15/2022 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213973s003lbl.pdf | |
09/15/2022 | SUPPL-3 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213973s003lbl.pdf | |
06/17/2021 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213973s001lbl.pdf | |
05/15/2020 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213973s000lbl.pdf |