{
  "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": "2026-08-21",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20110131",
          "submission_class_code": "N/A",
          "submission_class_code_description": "Not Applicable"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20211001",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20250915",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20180307",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20170207",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20220614",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20170207",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20120427",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "ANDA091483",
      "sponsor_name": "AMNEAL PHARMS",
      "openfda": {
        "application_number": [
          "ANDA091483"
        ],
        "brand_name": [
          "ONDANSETRON"
        ],
        "generic_name": [
          "ONDANSETRON"
        ],
        "manufacturer_name": [
          "AvPAK",
          "Amneal Pharmaceuticals LLC"
        ],
        "product_ndc": [
          "50268-647",
          "65162-691"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ONDANSETRON HYDROCHLORIDE"
        ],
        "rxcui": [
          "312085"
        ],
        "spl_id": [
          "47fb3120-1cb0-55b8-e063-6394a90a662a",
          "7421d60d-7d82-4ec5-885a-255c507c32a4"
        ],
        "spl_set_id": [
          "05cf8d4f-ac57-4177-e063-6394a90ae804",
          "38435346-d505-4bdd-bbc6-a7bcba411033"
        ],
        "package_ndc": [
          "50268-647-11",
          "50268-647-14",
          "65162-691-79",
          "65162-691-37",
          "65162-691-19"
        ],
        "unii": [
          "NMH84OZK2B"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "ONDANSETRON HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "ONDANSETRON HYDROCHLORIDE",
              "strength": "EQ 4MG BASE/5ML"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SOLUTION",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AA"
        }
      ]
    }
  ]
}