An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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
06/28/2024	SUPPL-36	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050794s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/050794Orig1s036ltr.pdf
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
06/28/2024	SUPPL-36	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050794s036lbl.pdf
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	215765	HETERO LABS LTD VI
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

Top