Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 211810
Company: DAIICHI SANKYO INC
Company: DAIICHI SANKYO INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TURALIO | PEXIDARTINIB HYDROCHLORIDE | EQ 200MG 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 |
|---|---|---|---|---|---|---|---|
| 08/02/2019 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211810s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211810Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211810Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/04/2020 | SUPPL-5 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211810Orig1s005ltr.pdf |
| 04/10/2020 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/17/2020 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211810s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211810Orig1s003ltr.pdf | |
| 11/19/2019 | SUPPL-2 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211810Orig1s001,s002ltr.pdf |
| 11/19/2019 | SUPPL-1 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211810Orig1s001,s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/17/2020 | SUPPL-3 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211810s003lbl.pdf | |
| 04/17/2020 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211810s003lbl.pdf | |
| 08/02/2019 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211810s000lbl.pdf |
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