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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022393
Company: BRISTOL-MYERS

Summary Review

Products on NDA 022393

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ISTODAX	ROMIDEPSIN	10MG/VIAL	POWDER;INTRAVENOUS	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022393

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-Patient Package Insert, Labeling-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-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

Labels for NDA 022393

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-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022393s015lbl.pdf
11/27/2018	SUPPL-15	Labeling-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-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

Therapeutic Equivalents for NDA 022393

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	BRISTOL-MYERS
ROMIDEPSIN	ROMIDEPSIN	10MG/VIAL	POWDER;INTRAVENOUS	Prescription	No	AP	206254	FRESENIUS KABI USA

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