Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202379
Company: JANSSEN BIOTECH
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 | AB | 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 |
|---|---|---|---|---|---|
| 08/23/2021 | SUPPL-35 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202379s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202379Orig1s035ltr.pdf | |
| 10/02/2020 | SUPPL-33 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202379s031s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202379Orig1s031,s033ltr.pdf | |
| 10/02/2020 | SUPPL-31 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202379s031s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202379Orig1s031,s033ltr.pdf | |
| 06/03/2019 | SUPPL-28 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202379s027s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202379Orig1s027, 202379Orig1s028ltr.pdf | |
| 06/03/2019 | SUPPL-27 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202379s027s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202379Orig1s027, 202379Orig1s028ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 08/23/2021 | SUPPL-35 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202379s035lbl.pdf | |
| 08/23/2021 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202379s035lbl.pdf | |
| 10/02/2020 | SUPPL-33 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202379s031s033lbl.pdf | |
| 10/02/2020 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202379s031s033lbl.pdf | |
| 10/02/2020 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202379s031s033lbl.pdf | |
| 10/02/2020 | SUPPL-31 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202379s031s033lbl.pdf | |
| 06/03/2019 | SUPPL-28 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202379s027s028lbl.pdf | |
| 06/03/2019 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202379s027s028lbl.pdf | |
| 06/03/2019 | SUPPL-27 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202379s027s028lbl.pdf | |
| 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 |
| ABIRATERONE ACETATE | ABIRATERONE ACETATE | 250MG | TABLET;ORAL | Prescription | No | AB | 208416 | DR REDDYS |
| ABIRATERONE ACETATE | ABIRATERONE ACETATE | 250MG | TABLET;ORAL | Prescription | No | AB | 209227 | GLENMARK PHARMS |
| ABIRATERONE ACETATE | ABIRATERONE ACETATE | 250MG | TABLET;ORAL | Prescription | No | AB | 208339 | HIKMA |
| ABIRATERONE ACETATE | ABIRATERONE ACETATE | 250MG | TABLET;ORAL | Prescription | No | AB | 210686 | MSN |
| ABIRATERONE ACETATE | ABIRATERONE ACETATE | 250MG | TABLET;ORAL | Prescription | No | AB | 208446 | MYLAN |
| ABIRATERONE ACETATE | ABIRATERONE ACETATE | 250MG | TABLET;ORAL | Prescription | No | AB | 215947 | NOVUGEN |
| ABIRATERONE ACETATE | ABIRATERONE ACETATE | 250MG | TABLET;ORAL | Prescription | No | AB | 212462 | QILU |
| ABIRATERONE ACETATE | ABIRATERONE ACETATE | 250MG | TABLET;ORAL | Prescription | No | AB | 208371 | RISING |
| 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 |
TABLET;ORAL; 500MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ABIRATERONE ACETATE | ABIRATERONE ACETATE | 500MG | TABLET;ORAL | Prescription | No | AB | 208327 | AMNEAL PHARMS |
| ABIRATERONE ACETATE | ABIRATERONE ACETATE | 500MG | TABLET;ORAL | Prescription | No | AB | 208416 | DR REDDYS |
| ABIRATERONE ACETATE | ABIRATERONE ACETATE | 500MG | TABLET;ORAL | Prescription | No | AB | 215086 | FLORIDA |
| ABIRATERONE ACETATE | ABIRATERONE ACETATE | 500MG | TABLET;ORAL | Prescription | No | AB | 209227 | GLENMARK PHARMS |
| ABIRATERONE ACETATE | ABIRATERONE ACETATE | 500MG | TABLET;ORAL | Prescription | No | AB | 210686 | MSN |
| ABIRATERONE ACETATE | ABIRATERONE ACETATE | 500MG | TABLET;ORAL | Prescription | No | AB | 208446 | MYLAN |
| ABIRATERONE ACETATE | ABIRATERONE ACETATE | 500MG | TABLET;ORAL | Prescription | No | AB | 215947 | NOVUGEN |
| ABIRATERONE ACETATE | ABIRATERONE ACETATE | 500MG | TABLET;ORAL | Prescription | No | AB | 212462 | QILU |
| ABIRATERONE ACETATE | ABIRATERONE ACETATE | 500MG | TABLET;ORAL | Prescription | No | AB | 210726 | TEVA PHARMS USA |
| ZYTIGA | ABIRATERONE ACETATE | 500MG | TABLET;ORAL | Prescription | Yes | AB | 202379 | JANSSEN BIOTECH |