{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-05-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20170822",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "49525",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203214s014s016,208246s001s002lbl.pdf",
              "date": "20170824",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "20",
          "submission_status": "AP",
          "submission_status_date": "20181018",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "56038",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203214s020,208246s006lbl.pdf",
              "date": "20181019",
              "type": "Label"
            },
            {
              "id": "56071",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203214Orig1s020,208246Orig1s006ltr.pdf",
              "date": "20181023",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20150619",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "40277",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203214s010lbl.pdf",
              "date": "20150623",
              "type": "Label"
            },
            {
              "id": "32394",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203214Orig1s010ltr.pdf",
              "date": "20150624",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20140507",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "10187",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203214Orig1s007ltr.pdf",
              "date": "20140508",
              "type": "Letter"
            },
            {
              "id": "19448",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203214s007lbl.pdf",
              "date": "20140512",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "39",
          "submission_status": "AP",
          "submission_status_date": "20251016",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "83813",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/203214Orig1s039, 213082Orig1s011ltr.pdf",
              "date": "20251020",
              "type": "Letter"
            },
            {
              "id": "83839",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/203214s039,213082s011lbl.pdf",
              "date": "20251021",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20140326",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "10186",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203214Orig1s005ltr.pdf",
              "date": "20140328",
              "type": "Letter"
            },
            {
              "id": "19447",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203214s005lbl.pdf",
              "date": "20140401",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20130503",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "41",
          "submission_status": "AP",
          "submission_status_date": "20260306",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "85301",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/203214Orig1s041,208246Orig1s027,213082Orig1s013ltr.pdf",
              "date": "20260309",
              "type": "Letter"
            },
            {
              "id": "85321",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/203214s041lbl.pdf",
              "date": "20260311",
              "type": "Label"
            },
            {
              "id": "85347",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/203214s041lbl.pdf#page=70",
              "date": "20260312",
              "type": "Medication Guide"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "25",
          "submission_status": "AP",
          "submission_status_date": "20191212",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "61268",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203214s025lbl.pdf",
              "date": "20191213",
              "type": "Label"
            },
            {
              "id": "61275",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203214Orig1s025ltr.pdf",
              "date": "20191213",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20171214",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "50700",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203214s017,208246s003lbl.pdf",
              "date": "20171215",
              "type": "Label"
            },
            {
              "id": "50708",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203214Orig1s017,208246ORig1s003ltr.pdf",
              "date": "20171215",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "31",
          "submission_status": "AP",
          "submission_status_date": "20211202",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "69472",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203214s031lbl.pdf",
              "date": "20211203",
              "type": "Label"
            },
            {
              "id": "69479",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/203214Orig1s031ltr.pdf",
              "date": "20211206",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "23",
          "submission_status": "AP",
          "submission_status_date": "20190830",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "59897",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203214Orig1s023, 208246Orig1s011_ltr.pdf",
              "date": "20190912",
              "type": "Letter"
            },
            {
              "id": "59899",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203214s023,208246s011lbl.pdf",
              "date": "20190830",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "20180817",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "55216",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203214Orig1s021,208246Orig1s007ltr.pdf",
              "date": "20180820",
              "type": "Letter"
            },
            {
              "id": "55259",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203214s021,208246s007lbl.pdf",
              "date": "20180821",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20160208",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "60746",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/203214Orig1s013.pdf",
              "date": "20191031",
              "type": "Review"
            },
            {
              "id": "32395",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203214Orig1s013ltr.pdf",
              "date": "20160209",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20151222",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "47468",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203214s011lbl.pdf",
              "date": "20170306",
              "type": "Label"
            },
            {
              "id": "10189",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203214Orig1s011ltr.pdf",
              "date": "20151223",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20150211",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "60745",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/203214Orig1s008.pdf",
              "date": "20191031",
              "type": "Review"
            },
            {
              "id": "10188",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203214Orig1s008ltr.pdf",
              "date": "20150217",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20131108",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "32393",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203214Orig1s006ltr.pdf",
              "date": "20131112",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "38",
          "submission_status": "AP",
          "submission_status_date": "20250221",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "81331",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/203214s038,208246s025,213082s010lbl.pdf",
              "date": "20250224",
              "type": "Label"
            },
            {
              "id": "81358",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/203214Orig1s038, 208246Orig1s025, 213082Orig1s010ltr.pdf",
              "date": "20250225",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20140221",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "53726",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203214Orig1s04.pdf",
              "date": "20180418",
              "type": "Review"
            },
            {
              "id": "10185",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203214Orig1s004ltr.pdf",
              "date": "20140225",
              "type": "Letter"
            },
            {
              "id": "19446",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203214s004lbl.pdf",
              "date": "20140225",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "36",
          "submission_status": "AP",
          "submission_status_date": "20240927",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "79768",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203214s036,208246s023,213082s008lbl.pdf",
              "date": "20240930",
              "type": "Label"
            },
            {
              "id": "79781",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/203214Orig1s036; 208246Orig1s023; 213082Orig1s008ltr.pdf",
              "date": "20240930",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20131118",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "40276",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203214s002lbl.pdf",
              "date": "20131122",
              "type": "Label"
            },
            {
              "id": "10184",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203214Orig1s002ltr.pdf",
              "date": "20131120",
              "type": "Letter"
            },
            {
              "id": "22916",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203214Orig1s002.pdf",
              "date": "20150925",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "28",
          "submission_status": "AP",
          "submission_status_date": "20211214",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "69562",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203214s028,208246s013,213082s003lbl.pdf",
              "date": "20211215",
              "type": "Label"
            },
            {
              "id": "69588",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/203214Orig1s028;208246Orig1s013;213082Orig1s003ltr.pdf",
              "date": "20211216",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "34",
          "submission_status": "AP",
          "submission_status_date": "20240514",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "78478",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203214s034,208246s021,213082s006lbl.pdf",
              "date": "20240515",
              "type": "Label"
            },
            {
              "id": "78509",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/203214Orig1s034;208246Orig1s021;213082Orig1s006ltr.pdf",
              "date": "20240520",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "26",
          "submission_status": "AP",
          "submission_status_date": "20200925",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "64736",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203214Orig1s026ltr.pdf",
              "date": "20200929",
              "type": "Letter"
            },
            {
              "id": "64752",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203214s026lbl.pdf",
              "date": "20200929",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "20180530",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "54373",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203214s018lbl.pdf",
              "date": "20180530",
              "type": "Label"
            },
            {
              "id": "54385",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203214Orig1s018ltr.pdf",
              "date": "20180531",
              "type": "Letter"
            },
            {
              "id": "72094",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/203214Orig1s018.pdf",
              "date": "20220916",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20121106",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "40275",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203214s000lbl.pdf",
              "date": "20121128",
              "type": "Label"
            },
            {
              "id": "43425",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203214Orig1s000TOC.html",
              "date": "20121218",
              "type": "Review"
            },
            {
              "id": "44880",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203214Orig1s000SumR.pdf",
              "date": "20121218",
              "type": "Summary Review"
            },
            {
              "id": "32392",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203214Orig1s000ltr.pdf",
              "date": "20121107",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "24",
          "submission_status": "AP",
          "submission_status_date": "20190725",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "59469",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203214Orig1s024, 208246Orig1s010ltr.pdf",
              "date": "20190726",
              "type": "Letter"
            },
            {
              "id": "59491",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203214s024,208246s010lbl.pdf",
              "date": "20190729",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20170822",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "49528",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203214s014s016,208246s001s002lbl.pdf",
              "date": "20170824",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA203214",
      "sponsor_name": "PF PRISM CV",
      "openfda": {
        "application_number": [
          "NDA203214"
        ],
        "brand_name": [
          "XELJANZ"
        ],
        "generic_name": [
          "TOFACITINIB"
        ],
        "manufacturer_name": [
          "Pfizer Laboratories Div Pfizer Inc",
          "U.S. Pharmaceuticals"
        ],
        "product_ndc": [
          "0069-1001",
          "0069-0501",
          "0069-1002",
          "0069-0502",
          "0069-1029",
          "63539-012",
          "63539-501",
          "63539-016",
          "63539-502",
          "63539-029"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "TOFACITINIB CITRATE"
        ],
        "rxcui": [
          "1357541",
          "1357547",
          "1741046",
          "1741049",
          "2048566",
          "2048568",
          "2273113",
          "2273115",
          "2478433",
          "2478437"
        ],
        "spl_id": [
          "39aa36a4-7b51-43af-9bf0-d812b3f9bd1d",
          "184c6caf-b874-4b42-9a0d-30219f3fd2ef"
        ],
        "spl_set_id": [
          "cf74ba2f-afc5-4baa-8594-979c889a5831",
          "68e3d6b2-7838-4d2d-a417-09d919b43e13"
        ],
        "package_ndc": [
          "0069-1001-01",
          "0069-0501-30",
          "0069-1002-01",
          "0069-0502-30",
          "0069-1029-01",
          "0069-1029-02",
          "63539-012-02",
          "63539-501-14",
          "63539-501-30",
          "63539-016-02",
          "63539-502-30",
          "63539-029-01",
          "63539-029-02"
        ],
        "unii": [
          "O1FF4DIV0D"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "XELJANZ",
          "active_ingredients": [
            {
              "name": "TOFACITINIB CITRATE",
              "strength": "EQ 10MG BASE"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "XELJANZ",
          "active_ingredients": [
            {
              "name": "TOFACITINIB CITRATE",
              "strength": "EQ 5MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}