{
  "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": "20230522",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN"
        }
      ],
      "application_number": "ANDA217314",
      "sponsor_name": "HAINAN POLY PHARM",
      "openfda": {
        "application_number": [
          "ANDA217314"
        ],
        "brand_name": [
          "LEVOLEUCOVORIN CALCIUM"
        ],
        "generic_name": [
          "LEVOLEUCOVORIN INJECTION"
        ],
        "manufacturer_name": [
          "Hainan Poly Pharm. Co., Ltd.",
          "Slate Run Pharmaceuticals"
        ],
        "product_ndc": [
          "14335-340",
          "14335-341",
          "70436-209",
          "70436-210"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "LEVOLEUCOVORIN CALCIUM"
        ],
        "rxcui": [
          "1720765",
          "1720773"
        ],
        "spl_id": [
          "fcf83646-5cb1-2844-e053-6294a90a8a92",
          "041b2b7e-33b8-a347-e063-6394a90acbc2"
        ],
        "spl_set_id": [
          "c10b0c18-dd7c-4a76-a79b-b8d38a08ab87",
          "124bc214-62f8-40f9-a227-a35e2d1ff2a0"
        ],
        "package_ndc": [
          "14335-340-01",
          "14335-341-01",
          "70436-209-80",
          "70436-210-80"
        ],
        "unii": [
          "778XL6VBS8"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "LEVOLEUCOVORIN CALCIUM",
          "active_ingredients": [
            {
              "name": "LEVOLEUCOVORIN CALCIUM",
              "strength": "EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SOLUTION",
          "route": "INTRAVENOUS",
          "marketing_status": "Prescription",
          "te_code": "AP"
        },
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "LEVOLEUCOVORIN CALCIUM",
          "active_ingredients": [
            {
              "name": "LEVOLEUCOVORIN CALCIUM",
              "strength": "EQ 250MG BASE/25ML (EQ 10MG BASE/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SOLUTION",
          "route": "INTRAVENOUS",
          "marketing_status": "Prescription",
          "te_code": "AP"
        }
      ]
    }
  ]
}