Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 203214
Company: PF PRISM CV
Company: PF PRISM CV
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| XELJANZ | TOFACITINIB CITRATE | EQ 5MG BASE | TABLET;ORAL | Prescription | None | Yes | No |
| XELJANZ | TOFACITINIB CITRATE | EQ 10MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 11/06/2012 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203214s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203214Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203214Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203214Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/14/2024 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203214s034,208246s021,213082s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/203214Orig1s034;208246Orig1s021;213082Orig1s006ltr.pdf | |
| 12/02/2021 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203214s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/203214Orig1s031ltr.pdf | |
| 12/14/2021 | SUPPL-28 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203214s028,208246s013,213082s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/203214Orig1s028;208246Orig1s013;213082Orig1s003ltr.pdf | |
| 09/25/2020 | SUPPL-26 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203214s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203214Orig1s026ltr.pdf | |
| 12/12/2019 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203214s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203214Orig1s025ltr.pdf | |
| 07/25/2019 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203214s024,208246s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203214Orig1s024, 208246Orig1s010ltr.pdf | |
| 08/30/2019 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203214s023,208246s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203214Orig1s023, 208246Orig1s011_ltr.pdf | |
| 08/17/2018 | SUPPL-21 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203214s021,208246s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203214Orig1s021,208246Orig1s007ltr.pdf | |
| 10/18/2018 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203214s020,208246s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203214Orig1s020,208246Orig1s006ltr.pdf | |
| 05/30/2018 | SUPPL-18 | Efficacy |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203214s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203214Orig1s018ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/203214Orig1s018.pdf | |
| 12/14/2017 | SUPPL-17 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203214s017,208246s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203214Orig1s017,208246ORig1s003ltr.pdf | |
| 08/22/2017 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203214s014s016,208246s001s002lbl.pdf | |
| 08/22/2017 | SUPPL-14 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203214s014s016,208246s001s002lbl.pdf | |
| 02/08/2016 | SUPPL-13 | REMS-Modified |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203214Orig1s013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/203214Orig1s013.pdf |
| 12/22/2015 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203214s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203214Orig1s011ltr.pdf | |
| 06/19/2015 | SUPPL-10 | Labeling-Medication Guide, REMS-Modified, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203214s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203214Orig1s010ltr.pdf | |
| 02/11/2015 | SUPPL-8 | REMS-Modified |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203214Orig1s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/203214Orig1s008.pdf |
| 05/07/2014 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203214s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203214Orig1s007ltr.pdf | |
| 11/08/2013 | SUPPL-6 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203214Orig1s006ltr.pdf |
| 03/26/2014 | SUPPL-5 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203214s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203214Orig1s005ltr.pdf | |
| 02/21/2014 | SUPPL-4 | Labeling-Package Insert, Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203214s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203214Orig1s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203214Orig1s04.pdf | |
| 11/18/2013 | SUPPL-2 | Labeling-Package Insert, Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203214s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203214Orig1s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203214Orig1s002.pdf | |
| 05/03/2013 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/14/2024 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203214s034,208246s021,213082s006lbl.pdf | |
| 12/14/2021 | SUPPL-28 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203214s028,208246s013,213082s003lbl.pdf | |
| 12/02/2021 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203214s031lbl.pdf | |
| 09/25/2020 | SUPPL-26 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203214s026lbl.pdf | |
| 12/12/2019 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203214s025lbl.pdf | |
| 08/30/2019 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203214s023,208246s011lbl.pdf | |
| 07/25/2019 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203214s024,208246s010lbl.pdf | |
| 10/18/2018 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203214s020,208246s006lbl.pdf | |
| 08/17/2018 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203214s021,208246s007lbl.pdf | |
| 08/17/2018 | SUPPL-21 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203214s021,208246s007lbl.pdf | |
| 05/30/2018 | SUPPL-18 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203214s018lbl.pdf | |
| 12/14/2017 | SUPPL-17 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203214s017,208246s003lbl.pdf | |
| 08/22/2017 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203214s014s016,208246s001s002lbl.pdf | |
| 08/22/2017 | SUPPL-14 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203214s014s016,208246s001s002lbl.pdf | |
| 12/22/2015 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203214s011lbl.pdf | |
| 06/19/2015 | SUPPL-10 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203214s010lbl.pdf | |
| 06/19/2015 | SUPPL-10 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203214s010lbl.pdf | |
| 06/19/2015 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203214s010lbl.pdf | |
| 05/07/2014 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203214s007lbl.pdf | |
| 03/26/2014 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203214s005lbl.pdf | |
| 03/26/2014 | SUPPL-5 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203214s005lbl.pdf | |
| 02/21/2014 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203214s004lbl.pdf | |
| 02/21/2014 | SUPPL-4 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203214s004lbl.pdf | |
| 11/18/2013 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203214s002lbl.pdf | |
| 11/18/2013 | SUPPL-2 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203214s002lbl.pdf | |
| 11/06/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203214s000lbl.pdf |