{
  "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": "20211129",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN",
          "application_docs": [
            {
              "id": "76506",
              "url": "https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37",
              "date": "20231107",
              "type": "REMS"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20240813",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20230110",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "ANDA214630",
      "sponsor_name": "BIOCON PHARMA",
      "openfda": {
        "application_number": [
          "ANDA214630"
        ],
        "brand_name": [
          "MYCOPHENOLIC ACID"
        ],
        "generic_name": [
          "MYCOPHENOLIC ACID"
        ],
        "manufacturer_name": [
          "Biocon Pharma Inc."
        ],
        "product_ndc": [
          "70377-039",
          "70377-040"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "MYCOPHENOLATE SODIUM"
        ],
        "rxcui": [
          "485020",
          "485023"
        ],
        "spl_id": [
          "c88acb03-1331-2837-85be-e4de5c5ad539"
        ],
        "spl_set_id": [
          "8516e135-5cc0-ef2d-6dad-0f9f841bb27b"
        ],
        "package_ndc": [
          "70377-039-11",
          "70377-040-11"
        ],
        "unii": [
          "WX877SQI1G"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "MYCOPHENOLATE SODIUM",
          "active_ingredients": [
            {
              "name": "MYCOPHENOLATE SODIUM",
              "strength": "EQ 180MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET, DELAYED RELEASE",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "MYCOPHENOLATE SODIUM",
          "active_ingredients": [
            {
              "name": "MYCOPHENOLATE SODIUM",
              "strength": "EQ 360MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET, DELAYED RELEASE",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}