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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213082
Company: PFIZER

Medication Guide

Products on NDA 213082

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
XELJANZ	TOFACITINIB CITRATE	EQ 1MG BASE/ML	SOLUTION;ORAL	Prescription	AA	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213082

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/25/2020	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213082s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213082Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213082Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/16/2025	SUPPL-11	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/203214s039,213082s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/203214Orig1s039, 213082Orig1s011ltr.pdf
02/21/2025	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/203214s038,208246s025,213082s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/203214Orig1s038, 208246Orig1s025, 213082Orig1s010ltr.pdf
09/27/2024	SUPPL-8	Labeling-Medication Guide	Label (PDF) Letter (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 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/203214Orig1s036; 208246Orig1s023; 213082Orig1s008ltr.pdf
05/14/2024	SUPPL-6	Labeling-Package Insert, Labeling-Medication Guide	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-4	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-3	Labeling-Package Insert, Labeling-Medication Guide	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

Labels for NDA 213082

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/16/2025	SUPPL-11	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/203214s039,213082s011lbl.pdf
02/21/2025	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/203214s038,208246s025,213082s010lbl.pdf
09/27/2024	SUPPL-8	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203214s036,208246s023,213082s008lbl.pdf
05/14/2024	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203214s034,208246s021,213082s006lbl.pdf
05/14/2024	SUPPL-6	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203214s034,208246s021,213082s006lbl.pdf
12/14/2021	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203214s028,208246s013,213082s003lbl.pdf
12/14/2021	SUPPL-3	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203214s028,208246s013,213082s003lbl.pdf
12/02/2021	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208246s017,213082s004lbl.pdf
09/25/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213082s000lbl.pdf

Therapeutic Equivalents for NDA 213082

XELJANZ

SOLUTION;ORAL; EQ 1MG BASE/ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
XELJANZ	TOFACITINIB CITRATE	EQ 1MG BASE/ML	SOLUTION;ORAL	Prescription	Yes	AA	213082	PFIZER

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