{
  "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": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20220527",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20170419",
          "review_priority": "UNKNOWN",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20160324",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20100607"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20191219",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20191219",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20170310",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "ANDA065496",
      "sponsor_name": "ALKEM LABS LTD",
      "openfda": {
        "application_number": [
          "ANDA065496"
        ],
        "brand_name": [
          "CEFUROXIME AXETIL"
        ],
        "generic_name": [
          "CEFUROXIME AXETIL"
        ],
        "manufacturer_name": [
          "Golden State Medical Supply, Inc.",
          "Major Pharmaceuticals",
          "Ascend Laboratories, LLC",
          "American Health Packaging"
        ],
        "product_ndc": [
          "51407-333",
          "51407-334",
          "0904-7542",
          "67877-215",
          "67877-216",
          "60687-272",
          "60687-283"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CEFUROXIME AXETIL"
        ],
        "rxcui": [
          "309097",
          "309098"
        ],
        "spl_id": [
          "502429f5-1f55-2030-e063-6394a90aef14",
          "8f3e739a-07d6-48a6-812f-49e049048bd3",
          "7c9fa966-9491-40a8-a57b-6f60dbf7bb55",
          "3bb8ed50-e786-f167-e063-6294a90a6031"
        ],
        "spl_set_id": [
          "bb7955fe-5111-1662-e053-2a95a90a85a1",
          "44e1fb4d-4b61-40da-9974-0bd2006eb828",
          "dd11e4b9-7730-4d3a-81ca-16f15de09759",
          "f38418a7-dd90-4f20-b747-7ac086c53015"
        ],
        "package_ndc": [
          "51407-334-20",
          "51407-334-60",
          "51407-333-20",
          "51407-333-60",
          "0904-7542-10",
          "67877-216-20",
          "67877-216-60",
          "67877-216-01",
          "67877-216-84",
          "67877-215-20",
          "67877-215-60",
          "67877-215-01",
          "67877-215-84",
          "60687-283-11",
          "60687-283-94",
          "60687-272-11",
          "60687-272-94"
        ],
        "unii": [
          "Z49QDT0J8Z"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "CEFUROXIME AXETIL",
          "active_ingredients": [
            {
              "name": "CEFUROXIME AXETIL",
              "strength": "EQ 500MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "CEFUROXIME AXETIL",
          "active_ingredients": [
            {
              "name": "CEFUROXIME AXETIL",
              "strength": "EQ 250MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}