Drugs@FDA: FDA Approved Drug Products
New Drug Application (NDA): 022393
Company: CELGENE
Company: CELGENE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ISTODAX | ROMIDEPSIN | 10MG/VIAL | 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 |
|---|---|---|---|---|---|---|---|
| 11/05/2009 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022393lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022393s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022393s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022393s000_SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/27/2018 | SUPPL-15 | Labeling-Package Insert, Labeling-Patient Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022393Orig1s015ltr.pdf |
| 07/27/2016 | SUPPL-14 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022393s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022393Orig1s014ltr.pdf | |
| 10/15/2014 | SUPPL-13 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022393s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022393Orig1s013ltr.pdf | |
| 09/13/2013 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/13/2013 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022393s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022393Orig1s011ltr.pdf | |
| 09/30/2011 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022393s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022393s006ltr.pdf | |
| 06/16/2011 | SUPPL-4 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022393s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022393s004ltr.pdf | |
| 04/12/2011 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022393s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022393s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/27/2016 | SUPPL-14 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022393s014lbl.pdf | |
| 10/15/2014 | SUPPL-13 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022393s013lbl.pdf | |
| 06/13/2013 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022393s011lbl.pdf | |
| 09/30/2011 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022393s006lbl.pdf | |
| 06/16/2011 | SUPPL-4 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022393s004lbl.pdf | |
| 04/12/2011 | SUPPL-1 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022393s001lbl.pdf | |
| 04/12/2011 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022393s001lbl.pdf | |
| 11/05/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022393lbl.pdf |
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