{
  "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": "13",
          "submission_status": "AP",
          "submission_status_date": "20191205",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20191205",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20191205",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20150320",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20191205",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20191205",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20140304",
          "submission_class_code": "UNKNOWN",
          "application_docs": [
            {
              "id": "10088",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202632Orig1s000ltr.pdf",
              "date": "20140306",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20191205",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20191205",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "ANDA202632",
      "sponsor_name": "AUROBINDO PHARMA LTD",
      "openfda": {
        "application_number": [
          "ANDA202632"
        ],
        "brand_name": [
          "MOXIFLOXACIN HYDROCHLORIDE"
        ],
        "generic_name": [
          "MOXIFLOXACIN HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Aurobindo Pharma Limited",
          "Rising Pharma Holdings, Inc."
        ],
        "product_ndc": [
          "65862-603",
          "57237-156"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "MOXIFLOXACIN HYDROCHLORIDE"
        ],
        "rxcui": [
          "311787"
        ],
        "spl_id": [
          "412cb5bf-66ad-4815-bf15-8d225c09260b",
          "20ac52fe-93eb-47c8-8bab-37f745f795fb"
        ],
        "spl_set_id": [
          "d6789c17-4a2f-4519-9060-e3b0dba422f0",
          "f34c08e6-fe74-4de3-9e36-a82c3c1c183b"
        ],
        "package_ndc": [
          "65862-603-30",
          "65862-603-99",
          "65862-603-10",
          "65862-603-55",
          "57237-156-30"
        ],
        "unii": [
          "C53598599T"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "MOXIFLOXACIN HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "MOXIFLOXACIN HYDROCHLORIDE",
              "strength": "EQ 400MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}