Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022393
Company: CELGENE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISTODAX ROMIDEPSIN 10MG/VIAL POWDER;INTRAVENOUS Prescription AP 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
07/30/2021 SUPPL-17 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022393s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022393Orig1s017ltr.pdf
03/24/2021 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022393Orig1s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022393Orig1s016ltr.pdf
11/27/2018 SUPPL-15 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022393s015lbl.pdf 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-Package Insert, Labeling-Container/Carton Labels 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
07/30/2021 SUPPL-17 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022393s017lbl.pdf
03/24/2021 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022393Orig1s016lbl.pdf
11/27/2018 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022393s015lbl.pdf
11/27/2018 SUPPL-15 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022393s015lbl.pdf
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022393s001lbl.pdf
04/12/2011 SUPPL-1 Labeling-Container/Carton Labels 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

ISTODAX

POWDER;INTRAVENOUS; 10MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ISTODAX ROMIDEPSIN 10MG/VIAL POWDER;INTRAVENOUS Prescription Yes AP 022393 CELGENE
ROMIDEPSIN ROMIDEPSIN 10MG/VIAL POWDER;INTRAVENOUS Prescription No AP 206254 FRESENIUS KABI USA

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