{
  "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": "1",
          "submission_status": "AP",
          "submission_status_date": "20241212",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "80567",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/204410Orig1s030;218490Orig1s001ltr.pdf",
              "date": "20241213",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20240322",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 4",
          "submission_class_code_description": "Type 4 - New Combination",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "77953",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218490Orig1s000ltr.pdf",
              "date": "20240325",
              "type": "Letter"
            },
            {
              "id": "77957",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218490s000lbl.pdf",
              "date": "20240325",
              "type": "Label"
            },
            {
              "id": "77958",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218490s000lbl.pdf#page=32",
              "date": "20240325",
              "type": "Medication Guide"
            },
            {
              "id": "79983",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/218490Orig1s000TOC.html",
              "date": "20241025",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20250402",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "81822",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218490s002lbl.pdf",
              "date": "20250403",
              "type": "Label"
            },
            {
              "id": "81891",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204410Orig1s031; 218490Orig1s002ltr.pdf",
              "date": "20250408",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA218490",
      "sponsor_name": "ACTELION",
      "openfda": {
        "application_number": [
          "NDA218490"
        ],
        "brand_name": [
          "OPSYNVI"
        ],
        "generic_name": [
          "MACITENTAN AND TADALAFIL"
        ],
        "manufacturer_name": [
          "Actelion Pharmaceuticals US, Inc."
        ],
        "product_ndc": [
          "66215-812",
          "66215-814"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "MACITENTAN",
          "TADALAFIL"
        ],
        "rxcui": [
          "2677765",
          "2677771",
          "2677773",
          "2677775"
        ],
        "spl_id": [
          "32840e17-39b6-50b2-e063-6394a90a7a37"
        ],
        "spl_set_id": [
          "6945b183-18d3-40de-afd1-c88e33cc1a63"
        ],
        "package_ndc": [
          "66215-814-30",
          "66215-814-01",
          "66215-814-10",
          "66215-812-07",
          "66215-812-30",
          "66215-812-01",
          "66215-812-08"
        ],
        "nui": [
          "N0000175599",
          "N0000020026",
          "N0000175581",
          "N0000175364"
        ],
        "pharm_class_epc": [
          "Phosphodiesterase 5 Inhibitor [EPC]",
          "Endothelin Receptor Antagonist [EPC]"
        ],
        "pharm_class_moa": [
          "Phosphodiesterase 5 Inhibitors [MoA]",
          "Endothelin Receptor Antagonists [MoA]"
        ],
        "unii": [
          "742SXX0ICT",
          "Z9K9Y9WMVL"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "OPSYNVI",
          "active_ingredients": [
            {
              "name": "MACITENTAN",
              "strength": "10MG"
            },
            {
              "name": "TADALAFIL",
              "strength": "40MG"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "OPSYNVI",
          "active_ingredients": [
            {
              "name": "MACITENTAN",
              "strength": "10MG"
            },
            {
              "name": "TADALAFIL",
              "strength": "20MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}