{
  "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": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20240726",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 5",
          "submission_class_code_description": "Type 5 - New Formulation or New Manufacturer",
          "application_docs": [
            {
              "id": "79241",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216352Orig1s000ltr.pdf",
              "date": "20240729",
              "type": "Letter"
            },
            {
              "id": "79248",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216352s000lbl.pdf",
              "date": "20240729",
              "type": "Label"
            },
            {
              "id": "82434",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/216352Orig1s000TOC.html",
              "date": "20250602",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20250122",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "81003",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/216352s001lbl.pdf",
              "date": "20250205",
              "type": "Label"
            },
            {
              "id": "81100",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/216352Orig1s001ltr.pdf",
              "date": "20250206",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA216352",
      "sponsor_name": "LUYE INNOMIND PHARMA",
      "openfda": {
        "application_number": [
          "NDA216352"
        ],
        "brand_name": [
          "ERZOFRI EXTENDED-RELEASE"
        ],
        "generic_name": [
          "PALIPERIDONE PALMITATE"
        ],
        "manufacturer_name": [
          "Shandong Luye Pharmaceutical Co., Ltd."
        ],
        "product_ndc": [
          "72526-105",
          "72526-106",
          "72526-107",
          "72526-108",
          "72526-109",
          "72526-110"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR"
        ],
        "substance_name": [
          "PALIPERIDONE PALMITATE"
        ],
        "rxcui": [
          "858048",
          "858052",
          "858054",
          "858056",
          "858073",
          "2699342",
          "2699348",
          "2699350",
          "2699351",
          "2699352",
          "2699353",
          "2699354"
        ],
        "spl_id": [
          "4c9a70a9-b1b5-b462-e063-6294a90adefd"
        ],
        "spl_set_id": [
          "492bf9dd-868e-421a-92db-8cca8973aac1"
        ],
        "package_ndc": [
          "72526-105-11",
          "72526-106-11",
          "72526-107-11",
          "72526-108-11",
          "72526-109-11",
          "72526-110-11",
          "72526-110-21"
        ],
        "unii": [
          "R8P8USM8FR"
        ]
      },
      "products": [
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "ERZOFRI",
          "active_ingredients": [
            {
              "name": "PALIPERIDONE PALMITATE",
              "strength": "117MG/0.75ML (117MG/0.75ML)"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SUSPENSION, EXTENDED RELEASE",
          "route": "INTRAMUSCULAR",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "ERZOFRI",
          "active_ingredients": [
            {
              "name": "PALIPERIDONE PALMITATE",
              "strength": "39MG/0.25ML (39MG/0.25ML)"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SUSPENSION, EXTENDED RELEASE",
          "route": "INTRAMUSCULAR",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "006",
          "reference_drug": "Yes",
          "brand_name": "ERZOFRI",
          "active_ingredients": [
            {
              "name": "PALIPERIDONE PALMITATE",
              "strength": "351MG/2.25ML (156MG/ML)"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SUSPENSION, EXTENDED RELEASE",
          "route": "INTRAMUSCULAR",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "004",
          "reference_drug": "Yes",
          "brand_name": "ERZOFRI",
          "active_ingredients": [
            {
              "name": "PALIPERIDONE PALMITATE",
              "strength": "156MG/ML (156MG/ML)"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SUSPENSION, EXTENDED RELEASE",
          "route": "INTRAMUSCULAR",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "ERZOFRI",
          "active_ingredients": [
            {
              "name": "PALIPERIDONE PALMITATE",
              "strength": "78MG/0.5ML (78MG/0.5ML)"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SUSPENSION, EXTENDED RELEASE",
          "route": "INTRAMUSCULAR",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "005",
          "reference_drug": "Yes",
          "brand_name": "ERZOFRI",
          "active_ingredients": [
            {
              "name": "PALIPERIDONE PALMITATE",
              "strength": "234MG/1.5ML (156MG/ML)"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SUSPENSION, EXTENDED RELEASE",
          "route": "INTRAMUSCULAR",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}