Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 209401
Company: CELATOR PHARMS
Company: CELATOR PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VYXEOS | CYTARABINE; DAUNORUBICIN | 100MG;44MG | POWDER;INTRAVENOUS | 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 |
---|---|---|---|---|---|---|---|
08/03/2017 | ORIG-1 | Approval | Type 4 - New Combination | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209401s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209401Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209401Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/27/2022 | SUPPL-11 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209401s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209401Orig1s011ltr.pdf | |
03/30/2021 | SUPPL-6 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209401s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209401Orig1s006ltr.pdf | |
01/13/2020 | SUPPL-2 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209401Orig1s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/27/2022 | SUPPL-11 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209401s011lbl.pdf | |
03/30/2021 | SUPPL-6 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209401s006lbl.pdf | |
08/03/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209401s000lbl.pdf |