{
  "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": "30",
          "submission_status": "TA",
          "submission_status_date": "20200819",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "66253",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021272Orig1s030ltr.pdf",
              "date": "20210217",
              "type": "Letter"
            },
            {
              "id": "66841",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021272Orig1s030lbl.pdf",
              "date": "20210323",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "22",
          "submission_status": "AP",
          "submission_status_date": "20160122",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "20",
          "submission_status": "AP",
          "submission_status_date": "20130926",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "42068",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021272Orig1s020.pdf",
              "date": "20140116",
              "type": "Review"
            },
            {
              "id": "4857",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021272Orig1s020ltredt.pdf",
              "date": "20131001",
              "type": "Letter"
            },
            {
              "id": "14825",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021272s020lbl.pdf",
              "date": "20130927",
              "type": "Label"
            },
            {
              "id": "27310",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021272Orig1s020ltr.pdf",
              "date": "20130926",
              "type": "Letter"
            },
            {
              "id": "36531",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021272s020lbledt.pdf",
              "date": "20130927",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20020521",
          "review_priority": "PRIORITY",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "14821",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21272lbl.pdf",
              "date": "20020521",
              "type": "Label"
            },
            {
              "id": "21562",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-272_Remodulin.html",
              "date": "20020731",
              "type": "Review"
            },
            {
              "id": "27304",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21272ini.pdf",
              "date": "20020521",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20080204",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "4855",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021272s009ltr.pdf",
              "date": "20080207",
              "type": "Letter"
            },
            {
              "id": "14824",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021272s009lbl.pdf",
              "date": "20080214",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "37",
          "submission_status": "AP",
          "submission_status_date": "20230307",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "73711",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021272Orig1s037ltr.pdf",
              "date": "20230308",
              "type": "Letter"
            },
            {
              "id": "74053",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021272Orig1s037lbl.pdf",
              "date": "20230425",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20060320",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "14822",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021272S005lbl.pdf",
              "date": "20060322",
              "type": "Label"
            },
            {
              "id": "21564",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021272Orig1s005.pdf",
              "date": "20151118",
              "type": "Review"
            },
            {
              "id": "27306",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021272S005ltr.pdf",
              "date": "20060323",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20141222",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "45363",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021272s019lbl.pdf",
              "date": "20160927",
              "type": "Label"
            },
            {
              "id": "27309",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021272Orig1s019ltr.pdf",
              "date": "20141230",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "25",
          "submission_status": "AP",
          "submission_status_date": "20180730",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "55068",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208276s000,021272s025lbl.pdf",
              "date": "20180731",
              "type": "Label"
            },
            {
              "id": "55082",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208276Orig1s000,021272Oirg1s025ltr.pdf",
              "date": "20180803",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20060120",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "27305",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021272s003ltr.pdf",
              "date": "20060130",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20110208",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "27308",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021272s015ltr.pdf",
              "date": "20110214",
              "type": "Letter"
            },
            {
              "id": "36530",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021272s015lbl.pdf",
              "date": "20110209",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "20140103",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20100108",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "4856",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021272s011ltr.pdf",
              "date": "20100115",
              "type": "Letter"
            },
            {
              "id": "36529",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021272s011lbl.pdf",
              "date": "20100112",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20080912",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "14823",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021272s008lbl.pdf",
              "date": "20080919",
              "type": "Label"
            },
            {
              "id": "27307",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021272s008ltr.pdf",
              "date": "20080916",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "26",
          "submission_status": "AP",
          "submission_status_date": "20180608",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "54538",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021272s026lbl.pdf",
              "date": "20180612",
              "type": "Label"
            },
            {
              "id": "54561",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021272Orig1s026ltr.pdf",
              "date": "20180614",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "32",
          "submission_status": "AP",
          "submission_status_date": "20210730",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "68585",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021272Orig1s032ltr.pdf",
              "date": "20210913",
              "type": "Letter"
            },
            {
              "id": "68588",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021272Orig1s032lbl.pdf",
              "date": "20210913",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20041124",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "21563",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021272Orig1s002.pdf",
              "date": "20111010",
              "type": "Review"
            }
          ]
        }
      ],
      "application_number": "NDA021272",
      "sponsor_name": "UNITED THERAP",
      "openfda": {
        "application_number": [
          "NDA021272"
        ],
        "brand_name": [
          "REMODULIN",
          "STERILE DILUENT FOR REMODULIN"
        ],
        "generic_name": [
          "TREPROSTINIL",
          "WATER"
        ],
        "manufacturer_name": [
          "United Therapeutics Corporation"
        ],
        "product_ndc": [
          "66302-101",
          "66302-111",
          "66302-112",
          "66302-114",
          "66302-102",
          "66302-105",
          "66302-110",
          "66302-120",
          "66302-150"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS",
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "TREPROSTINIL",
          "WATER"
        ],
        "rxcui": [
          "349407",
          "349408",
          "349409",
          "349410",
          "352211",
          "352212",
          "352213",
          "352214",
          "2590175",
          "2590177",
          "2667748",
          "2667750",
          "2667752",
          "2667754",
          "2667756",
          "2667758"
        ],
        "spl_id": [
          "143d514e-fdcd-4766-ba47-0a75395e1f84"
        ],
        "spl_set_id": [
          "6c80bb38-e8db-4138-9f0d-dbbf9c673185"
        ],
        "package_ndc": [
          "66302-111-01",
          "66302-112-01",
          "66302-114-01",
          "66302-101-01",
          "66302-102-01",
          "66302-105-01",
          "66302-110-01",
          "66302-120-01",
          "66302-150-50"
        ],
        "nui": [
          "N0000175416",
          "M0017817",
          "N0000009909"
        ],
        "pharm_class_epc": [
          "Prostacycline Vasodilator [EPC]"
        ],
        "pharm_class_cs": [
          "Prostaglandins I [CS]"
        ],
        "pharm_class_pe": [
          "Vasodilation [PE]"
        ],
        "unii": [
          "059QF0KO0R",
          "RUM6K67ESG"
        ]
      },
      "products": [
        {
          "product_number": "007",
          "reference_drug": "Yes",
          "brand_name": "REMODULIN",
          "active_ingredients": [
            {
              "name": "TREPROSTINIL",
              "strength": "0.2MG/ML"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INTRAVENOUS, SUBCUTANEOUS",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "005",
          "reference_drug": "Yes",
          "brand_name": "REMODULIN",
          "active_ingredients": [
            {
              "name": "TREPROSTINIL",
              "strength": "20MG/ML"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INTRAVENOUS, SUBCUTANEOUS",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "REMODULIN",
          "active_ingredients": [
            {
              "name": "TREPROSTINIL",
              "strength": "5MG/ML"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "INJECTABLE",
          "route": "INTRAVENOUS, SUBCUTANEOUS",
          "marketing_status": "Prescription",
          "te_code": "AP"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "REMODULIN",
          "active_ingredients": [
            {
              "name": "TREPROSTINIL",
              "strength": "1MG/ML"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "INJECTABLE",
          "route": "INTRAVENOUS, SUBCUTANEOUS",
          "marketing_status": "Prescription",
          "te_code": "AP"
        },
        {
          "product_number": "008",
          "reference_drug": "Yes",
          "brand_name": "REMODULIN",
          "active_ingredients": [
            {
              "name": "TREPROSTINIL",
              "strength": "0.4MG/ML"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "INJECTABLE",
          "route": "INTRAVENOUS, SUBCUTANEOUS",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "006",
          "reference_drug": "Yes",
          "brand_name": "REMODULIN",
          "active_ingredients": [
            {
              "name": "TREPROSTINIL",
              "strength": "0.1MG/ML"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INTRAVENOUS, SUBCUTANEOUS",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "004",
          "reference_drug": "Yes",
          "brand_name": "REMODULIN",
          "active_ingredients": [
            {
              "name": "TREPROSTINIL",
              "strength": "10MG/ML"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "INJECTABLE",
          "route": "INTRAVENOUS, SUBCUTANEOUS",
          "marketing_status": "Prescription",
          "te_code": "AP"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "REMODULIN",
          "active_ingredients": [
            {
              "name": "TREPROSTINIL",
              "strength": "2.5MG/ML"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "INJECTABLE",
          "route": "INTRAVENOUS, SUBCUTANEOUS",
          "marketing_status": "Prescription",
          "te_code": "AP"
        }
      ]
    }
  ]
}