Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050794
Company: CELGENE
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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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 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 210748 LUPIN LTD
AZACITIDINE AZACITIDINE 100MG/VIAL POWDER;INTRAVENOUS, SUBCUTANEOUS Prescription No AP 204949 MYLAN INSTITUTIONAL
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 CELGENE

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