{
  "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": "2026-06-09",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20230303",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "73684",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/203109Orig1s016;022473Orig1s016ltr.pdf",
              "date": "20230306",
              "type": "Letter"
            },
            {
              "id": "73688",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203109s016,022473s176lbl.pdf",
              "date": "20230306",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20140821",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20140131",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "38751",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s012s013,022473s005s006,203109s003s004lbl.pdf",
              "date": "20140203",
              "type": "Label"
            },
            {
              "id": "7445",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s012,013;022473Orig1s005,006;203109Orig1s003,004ltr.pdf",
              "date": "20140204",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20190117",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "57243",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022473s012,203109s012lbl.pdf",
              "date": "20190118",
              "type": "Label"
            },
            {
              "id": "57316",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022473Orig1s012,203109Orig1s012ltr.pdf",
              "date": "20190122",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20140311",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "38750",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s011,022473s004,0203109s002lbl.pdf",
              "date": "20140313",
              "type": "Label"
            },
            {
              "id": "7443",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s011,022473Orig1s004,203109Origs002ltr.pdf",
              "date": "20140313",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20150427",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "17631",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021845s016,022473s010,203109s009lbl.pdf",
              "date": "20150512",
              "type": "Label"
            },
            {
              "id": "29767",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021845Orig1s016,022473Orig1s010,203109Origs009ltr.pdf",
              "date": "20150429",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20241216",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "85166",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021845Orig1s028,022473Orig1s019lbl.pdf",
              "date": "20260219",
              "type": "Label"
            },
            {
              "id": "85167",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/021845Orig1s028,022473Orig1s019ltr.pdf",
              "date": "20260219",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20140306",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "38752",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s014,022473s007,203109s005lbl.pdf",
              "date": "20140307",
              "type": "Label"
            },
            {
              "id": "7446",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s014,022473Orig1s007,203109Orig1s005ltr.pdf",
              "date": "20140307",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20140131",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "7444",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021845Orig1s012,013;022473Orig1s005,006;203109Orig1s003,004ltr.pdf",
              "date": "20140204",
              "type": "Letter"
            },
            {
              "id": "17630",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021845s012s013,022473s005s006,203109s003s004lbl.pdf",
              "date": "20140203",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20091118",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "38749",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022473lbl.pdf",
              "date": "20091120",
              "type": "Label"
            },
            {
              "id": "42534",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022473_revatio_toc.html",
              "date": "20100218",
              "type": "Review"
            },
            {
              "id": "7441",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022473s000ltr.pdf",
              "date": "20091120",
              "type": "Letter"
            },
            {
              "id": "24317",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022473s000_SumR.pdf",
              "date": "20100218",
              "type": "Summary Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20170731",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "50674",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203109s011,022473s011,021845s020lbl.pdf",
              "date": "20171213",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20120830",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "7442",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022473Orig1s003ltr.pdf",
              "date": "20120905",
              "type": "Letter"
            },
            {
              "id": "17629",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022473s003lbl.pdf",
              "date": "20120906",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20101119",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "17628",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021845s007,022473s001lbl.pdf",
              "date": "20101126",
              "type": "Label"
            },
            {
              "id": "29766",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021845s007,022473s001ltr.pdf",
              "date": "20101122",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA022473",
      "sponsor_name": "VIATRIS",
      "openfda": {
        "application_number": [
          "NDA022473"
        ],
        "brand_name": [
          "REVATIO"
        ],
        "generic_name": [
          "SILDENAFIL CITRATE"
        ],
        "manufacturer_name": [
          "Viatris Specialty LLC"
        ],
        "product_ndc": [
          "58151-395",
          "58151-402",
          "58151-385"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "SILDENAFIL CITRATE"
        ],
        "rxcui": [
          "577033",
          "581645",
          "882527",
          "882530",
          "1307427",
          "1307431"
        ],
        "spl_id": [
          "3fa2b889-ff04-4db1-b2c8-c0238efe240b"
        ],
        "spl_set_id": [
          "3bb9363e-b28d-4019-8aae-539233dca214"
        ],
        "package_ndc": [
          "58151-402-77",
          "58151-395-31",
          "58151-385-35"
        ],
        "unii": [
          "BW9B0ZE037"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "REVATIO",
          "active_ingredients": [
            {
              "name": "SILDENAFIL CITRATE",
              "strength": "EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SOLUTION",
          "route": "INTRAVENOUS",
          "marketing_status": "Prescription",
          "te_code": "AP"
        }
      ]
    }
  ]
}