FDA Approval for IDHIFA issued to CELGENE CORP
$CELG~
New Drug Application (NDA): 209606
Company: CELGENE CORP
Company: CELGENE CORP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IDHIFA | ENASIDENIB MESYLATE | EQ 50MG BASE | TABLET;ORAL | Prescription | None | Yes | No |
| IDHIFA | ENASIDENIB MESYLATE | EQ 100MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 08/01/2017 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209606s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209606Orig1s000.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209606Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/26/2021 | SUPPL-5 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209606Orig1s005ltr.pdf |
| 11/24/2020 | SUPPL-4 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209606s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209606Orig1s004ltr.pdf | |
| 09/27/2019 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209606s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209606Orig1s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/24/2020 | SUPPL-4 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209606s004lbl.pdf | |
| 09/27/2019 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209606s002lbl.pdf | |
| 08/01/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209606s000lbl.pdf |