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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208246
Company: PFIZER

Medication Guide

Products on NDA 208246

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
XELJANZ XR	TOFACITINIB CITRATE	EQ 11MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	Yes	No
XELJANZ XR	TOFACITINIB CITRATE	EQ 22MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208246

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/23/2016	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208246s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208246Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208246Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/27/2024	SUPPL-23	Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203214s036,208246s023,213082s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/203214Orig1s036; 208246Orig1s023; 213082Orig1s008ltr.pdf
05/14/2024	SUPPL-21	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-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208246s017,213082s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208246Orig1s017; 213082Orig1s004ltr.pdf
12/14/2021	SUPPL-13	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
08/30/2019	SUPPL-11	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
07/25/2019	SUPPL-10	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
12/12/2019	SUPPL-9	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208246s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208246Orig1s009ltr.pdf
08/17/2018	SUPPL-7	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-6	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
12/14/2017	SUPPL-3	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-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203214s014s016,208246s001s002lbl.pdf
08/22/2017	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203214s014s016,208246s001s002lbl.pdf

Labels for NDA 208246

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/27/2024	SUPPL-23	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203214s036,208246s023,213082s008lbl.pdf
05/14/2024	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203214s034,208246s021,213082s006lbl.pdf
12/14/2021	SUPPL-13	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203214s028,208246s013,213082s003lbl.pdf
12/02/2021	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208246s017,213082s004lbl.pdf
12/12/2019	SUPPL-9	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208246s009lbl.pdf
08/30/2019	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203214s023,208246s011lbl.pdf
07/25/2019	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203214s024,208246s010lbl.pdf
10/18/2018	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203214s020,208246s006lbl.pdf
08/17/2018	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203214s021,208246s007lbl.pdf
12/14/2017	SUPPL-3	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203214s017,208246s003lbl.pdf
08/22/2017	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203214s014s016,208246s001s002lbl.pdf
08/22/2017	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203214s014s016,208246s001s002lbl.pdf
02/23/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208246s000lbl.pdf

Therapeutic Equivalents for NDA 208246

XELJANZ XR

TABLET, EXTENDED RELEASE;ORAL; EQ 11MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TOFACITINIB CITRATE	TOFACITINIB CITRATE	EQ 11MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	218668	DEXCEL
XELJANZ XR	TOFACITINIB CITRATE	EQ 11MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	208246	PFIZER

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