{
  "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": "20231122",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN"
        }
      ],
      "application_number": "ANDA215469",
      "sponsor_name": "STRIDES PHARMA INTL",
      "openfda": {
        "application_number": [
          "ANDA215469"
        ],
        "brand_name": [
          "SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE ORAL"
        ],
        "generic_name": [
          "SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE ORAL"
        ],
        "manufacturer_name": [
          "Strides Pharma Science Limited"
        ],
        "product_ndc": [
          "64380-116"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "MAGNESIUM SULFATE, UNSPECIFIED FORM",
          "POTASSIUM SULFATE",
          "SODIUM SULFATE"
        ],
        "rxcui": [
          "1120068"
        ],
        "spl_id": [
          "2c66ebff-4389-49f9-a6ed-39d7de46dcb5"
        ],
        "spl_set_id": [
          "d48d8c59-68b9-4e28-86a4-eabf8b2003b0"
        ],
        "package_ndc": [
          "64380-116-02",
          "64380-116-01"
        ],
        "unii": [
          "DE08037SAB",
          "1K573LC5TV",
          "0YPR65R21J"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE",
          "active_ingredients": [
            {
              "name": "MAGNESIUM SULFATE",
              "strength": "1.6GM/BOT"
            },
            {
              "name": "POTASSIUM SULFATE",
              "strength": "3.13GM/BOT"
            },
            {
              "name": "SODIUM SULFATE",
              "strength": "17.5GM/BOT"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SOLUTION",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AA"
        }
      ]
    }
  ]
}