Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 202379
Company: JANSSEN BIOTECH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZYTIGA ABIRATERONE ACETATE 250MG TABLET;ORAL Prescription AB Yes No
ZYTIGA ABIRATERONE ACETATE 500MG TABLET;ORAL Prescription None 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
04/28/2011 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202379lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202379s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202379Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202379Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/25/2018 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202379s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202379Orig1s025ltr.pdf
02/07/2018 SUPPL-24 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202379s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202379Orig1s024ltr.pdf
05/17/2016 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202379s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202379Orig1s023ltr.pdf
12/10/2015 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202379s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202379Orig1s021ltr.pdf
08/18/2015 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

05/20/2015 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202379s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202379Orig1s018ltr.pdf
03/03/2015 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

03/20/2015 SUPPL-16 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202379s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202379Orig1s016ltr.pdf
01/23/2015 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202379s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202379Orig1s015ltr.pdf
01/20/2015 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

11/16/2014 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/17/2014 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/01/2014 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/13/2014 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202379s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202379Orig1s009ltr.pdf
02/07/2014 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/12/2013 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202379s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202379Orig1s007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/review/2018/202379Orig1s007.pdf
06/17/2013 SUPPL-6 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202379Orig1s006.pdf
12/10/2012 SUPPL-5 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202379s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202379Orig1s005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202379Orig1s005.pdf
09/17/2012 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202379s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202379Orig1s004ltr.pdf
07/03/2012 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202379s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202379s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/25/2018 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202379s025lbl.pdf
02/07/2018 SUPPL-24 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202379s024lbl.pdf
05/17/2016 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202379s023lbl.pdf
12/10/2015 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202379s021lbl.pdf
05/20/2015 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202379s018lbl.pdf
03/20/2015 SUPPL-16 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202379s016lbl.pdf
01/23/2015 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202379s015lbl.pdf
05/13/2014 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202379s009lbl.pdf
09/12/2013 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202379s007lbl.pdf
12/10/2012 SUPPL-5 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202379s005lbl.pdf
09/17/2012 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202379s004lbl.pdf
07/03/2012 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202379s003lbl.pdf
04/28/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202379lbl.pdf

ZYTIGA

TABLET;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ABIRATERONE ACETATE ABIRATERONE ACETATE 250MG TABLET;ORAL Prescription No AB 208327 AMNEAL PHARMS
ABIRATERONE ACETATE ABIRATERONE ACETATE 250MG TABLET;ORAL Prescription No AB 208453 APOTEX INC
ABIRATERONE ACETATE ABIRATERONE ACETATE 250MG TABLET;ORAL Prescription No AB 208339 HIKMA PHARMS
ABIRATERONE ACETATE ABIRATERONE ACETATE 250MG TABLET;ORAL Prescription No AB 208446 MYLAN
ABIRATERONE ACETATE ABIRATERONE ACETATE 250MG TABLET;ORAL Prescription No AB 208371 RISING PHARMS
ABIRATERONE ACETATE ABIRATERONE ACETATE 250MG TABLET;ORAL Prescription No AB 208432 TEVA PHARMS USA
ABIRATERONE ACETATE ABIRATERONE ACETATE 250MG TABLET;ORAL Prescription No AB 208380 WOCKHARDT BIO AG
ZYTIGA ABIRATERONE ACETATE 250MG TABLET;ORAL Prescription Yes AB 202379 JANSSEN BIOTECH

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