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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050794
Company: BRISTOL-MYERS

Products on NDA 050794

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VIDAZA	AZACITIDINE	100MG/VIAL	POWDER;INTRAVENOUS, SUBCUTANEOUS	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050794

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/19/2004	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/050794lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50794ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/50-794_Vidaza.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/23/2022	SUPPL-35	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050794s035lbl.pdf
05/20/2022	SUPPL-34	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050974s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050794Orig1s034ltr.pdf
03/18/2020	SUPPL-32	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050794s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050794Orig1s032ltr.pdf
07/20/2018	SUPPL-31	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050794s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050794Orig1s031ltr.pdf
01/30/2017	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
08/23/2016	SUPPL-29	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050794s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050794Orig1s029ltr.pdf
12/17/2015	SUPPL-28	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050794s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050794Orig1s028ltr.pdf
02/23/2015	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
01/10/2014	SUPPL-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050794s026lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050794Orig1s026ltr.pdf
05/06/2013	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
12/19/2012	SUPPL-24	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050794s024lbl.pdf
01/24/2012	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050794s023LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050794s023ltr.pdf
08/17/2011	SUPPL-20	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050794s016s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050794s016,050794s020ltr.pdf
08/17/2011	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050794s016s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050794s016,050794s020ltr.pdf
08/20/2008	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050794s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050794s011ltr.pdf
02/22/2008	SUPPL-10	Labeling-Container/Carton Labels, Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050794s010ltr.pdf
01/26/2007	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050794s005lbl.pdf
06/29/2005	SUPPL-1	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050794s001ltr.pdf

Labels for NDA 050794

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/23/2022	SUPPL-35	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050794s035lbl.pdf
05/20/2022	SUPPL-34	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050974s034lbl.pdf
03/18/2020	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050794s032lbl.pdf
07/20/2018	SUPPL-31	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050794s031lbl.pdf
08/23/2016	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050794s029lbl.pdf
12/17/2015	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050794s028lbl.pdf
01/10/2014	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050794s026lbledt.pdf
12/19/2012	SUPPL-24	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050794s024lbl.pdf
01/24/2012	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050794s023LBL.pdf
08/17/2011	SUPPL-20	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050794s016s020lbl.pdf
08/17/2011	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050794s016s020lbl.pdf
08/20/2008	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050794s011lbl.pdf
01/26/2007	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050794s005lbl.pdf
05/19/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/050794lbl.pdf

Therapeutic Equivalents for NDA 050794

VIDAZA

POWDER;INTRAVENOUS, SUBCUTANEOUS; 100MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AZACITIDINE	AZACITIDINE	100MG/VIAL	POWDER;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	207475	ACCORD HLTHCARE
AZACITIDINE	AZACITIDINE	100MG/VIAL	POWDER;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	208216	ACTAVIS LLC
AZACITIDINE	AZACITIDINE	100MG/VIAL	POWDER;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	211549	AMNEAL
AZACITIDINE	AZACITIDINE	100MG/VIAL	POWDER;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	209540	CIPLA
AZACITIDINE	AZACITIDINE	100MG/VIAL	POWDER;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	201537	DR REDDYS
AZACITIDINE	AZACITIDINE	100MG/VIAL	POWDER;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	215066	EUGIA PHARMA
AZACITIDINE	AZACITIDINE	100MG/VIAL	POWDER;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	209337	EUROHLTH INTL SARL
AZACITIDINE	AZACITIDINE	100MG/VIAL	POWDER;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	215905	JIANGSU HANSOH PHARM
AZACITIDINE	AZACITIDINE	100MG/VIAL	POWDER;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	212128	MEITHEAL
AZACITIDINE	AZACITIDINE	100MG/VIAL	POWDER;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	212580	MSN LABS PVT LTD
AZACITIDINE	AZACITIDINE	100MG/VIAL	POWDER;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	207234	NATCO PHARMA LTD
AZACITIDINE	AZACITIDINE	100MG/VIAL	POWDER;INTRAVENOUS, SUBCUTANEOUS	Prescription	No	AP	207518	SHILPA MEDICARE
VIDAZA	AZACITIDINE	100MG/VIAL	POWDER;INTRAVENOUS, SUBCUTANEOUS	Prescription	Yes	AP	050794	BRISTOL-MYERS

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