Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 203214
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
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-Container/Carton Labels, Labeling-Package Insert 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)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203214s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203214Orig1s018ltr.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)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203214Orig1s013ltr.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, Labeling-Package Insert, REMS-Modified 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)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203214Orig1s008ltr.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-Medication Guide, Labeling-Package Insert 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 Efficacy-Labeling Change With Clinical Data, Labeling-Package Insert 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 Efficacy-Labeling Change With Clinical Data, Labeling-Package Insert 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
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-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203214s021,208246s007lbl.pdf
08/17/2018 SUPPL-21 Labeling-Package Insert 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 Labeling-Package Insert 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
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-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203214s005lbl.pdf
03/26/2014 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203214s005lbl.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
02/21/2014 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203214s004lbl.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
11/18/2013 SUPPL-2 Labeling-Package Insert 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

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