Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 213082
Company: PFIZER
Company: PFIZER
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 |
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 |
---|---|---|---|---|---|
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-Medication Guide, Labeling-Package Insert |
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 |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
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-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203214s028,208246s013,213082s003lbl.pdf | |
12/14/2021 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203214s028,208246s013,213082s003lbl.pdf | |
12/02/2021 | 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 |
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 |