{
  "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": "20251002",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN"
        }
      ],
      "application_number": "ANDA219721",
      "sponsor_name": "ANNORA PHARMA",
      "openfda": {
        "application_number": [
          "ANDA219721"
        ],
        "brand_name": [
          "MIRTAZAPINE"
        ],
        "generic_name": [
          "MIRTAZAPINE"
        ],
        "manufacturer_name": [
          "Camber Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "31722-407",
          "31722-408",
          "31722-409",
          "31722-410"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "MIRTAZAPINE"
        ],
        "rxcui": [
          "311725",
          "311726",
          "314111",
          "476809"
        ],
        "spl_id": [
          "4e8e5591-9b05-8885-e063-6394a90a02e8"
        ],
        "spl_set_id": [
          "b4b9b66e-87a1-4dbb-9eaf-71221bcb2265"
        ],
        "package_ndc": [
          "31722-407-30",
          "31722-407-05",
          "31722-408-30",
          "31722-408-10",
          "31722-408-05",
          "31722-409-30",
          "31722-409-05",
          "31722-410-30",
          "31722-410-05"
        ],
        "unii": [
          "A051Q2099Q"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "MIRTAZAPINE",
          "active_ingredients": [
            {
              "name": "MIRTAZAPINE",
              "strength": "7.5MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "004",
          "reference_drug": "No",
          "brand_name": "MIRTAZAPINE",
          "active_ingredients": [
            {
              "name": "MIRTAZAPINE",
              "strength": "45MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "MIRTAZAPINE",
          "active_ingredients": [
            {
              "name": "MIRTAZAPINE",
              "strength": "15MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "003",
          "reference_drug": "No",
          "brand_name": "MIRTAZAPINE",
          "active_ingredients": [
            {
              "name": "MIRTAZAPINE",
              "strength": "30MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}