Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | EQ 5MG BASE | 1 | XELJANZ | TOFACITINIB CITRATE |
| 002 | TABLET;ORAL | EQ 10MG BASE | 1 | XELJANZ | TOFACITINIB CITRATE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2012-11-06 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 2013-11-18 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2014-02-21 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2014-03-26 | STANDARD |
| REMS; REMS | SUPPL | 6 | AP | 2013-11-08 | N/A |
| LABELING; Labeling | SUPPL | 7 | AP | 2014-05-07 | STANDARD |
| REMS; REMS | SUPPL | 8 | AP | 2015-02-11 | N/A |
| LABELING; Labeling | SUPPL | 10 | AP | 2015-06-19 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2015-12-22 | STANDARD |
| REMS; REMS | SUPPL | 13 | AP | 2016-02-08 | N/A |
| EFFICACY; Efficacy | SUPPL | 14 | AP | 2017-08-22 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2017-08-22 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 17 | AP | 2017-12-14 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 18 | AP | 2018-05-30 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2018-10-18 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2018-08-17 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2019-08-30 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2019-07-25 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2019-12-12 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 26 | AP | 2020-09-25 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 28 | AP | 2021-12-14 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 2021-12-02 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 5 | Null | 6 |
| SUPPL | 6 | Null | 6 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 11 | Null | 15 |
| SUPPL | 13 | Null | 7 |
| SUPPL | 14 | Null | 15 |
| SUPPL | 16 | Null | 15 |
| SUPPL | 17 | Null | 6 |
| SUPPL | 18 | Null | 6 |
| SUPPL | 20 | Null | 15 |
| SUPPL | 21 | Null | 6 |
| SUPPL | 23 | Null | 15 |
| SUPPL | 24 | Null | 6 |
| SUPPL | 25 | Null | 7 |
| SUPPL | 26 | Null | 7 |
| SUPPL | 28 | Null | 7 |
| SUPPL | 31 | Null | 7 |
TE Codes
CDER Filings
PF PRISM CV
cder:Array
(
[0] => Array
(
[ApplNo] => 203214
[companyName] => PF PRISM CV
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/203214s028,208246s013,213082s003lbl.pdf#page=66"]
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[originalApprovals] => [{"actionDate":"11\/06\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/203214s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/203214Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/203214Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/203214Orig1s000SumR.pdf\"}]","notes":">"}]
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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/203214s017,208246s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/203214Orig1s017,208246ORig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"08\/22\/2017","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/203214s014s016,208246s001s002lbl.pdf\"}]","notes":">"},{"actionDate":"08\/22\/2017","submission":"SUPPL-14","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/203214s014s016,208246s001s002lbl.pdf\"}]","notes":">"},{"actionDate":"02\/08\/2016","submission":"SUPPL-13","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/203214Orig1s013ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/203214Orig1s013.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"12\/22\/2015","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203214s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/203214Orig1s011ltr.pdf\"}]","notes":">"},{"actionDate":"06\/19\/2015","submission":"SUPPL-10","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert, REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203214s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/203214Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"02\/11\/2015","submission":"SUPPL-8","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/203214Orig1s008ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/203214Orig1s008.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"05\/07\/2014","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203214s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/203214Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"11\/08\/2013","submission":"SUPPL-6","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/203214Orig1s006ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"03\/26\/2014","submission":"SUPPL-5","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203214s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/203214Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"02\/21\/2014","submission":"SUPPL-4","supplementCategories":"Efficacy-Labeling Change With Clinical Data, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203214s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/203214Orig1s004ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/203214Orig1s04.pdf\"}]","notes":">"},{"actionDate":"11\/18\/2013","submission":"SUPPL-2","supplementCategories":"Efficacy-Labeling Change With Clinical Data, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203214s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/203214Orig1s002ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/203214Orig1s002.pdf\"}]","notes":">"},{"actionDate":"05\/03\/2013","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2021-12-14
)
)