{
  "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": "3",
          "submission_status": "AP",
          "submission_status_date": "20080731",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19980205",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20210428",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20160509",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20241121",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20060808",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19930527"
        }
      ],
      "application_number": "ANDA073393",
      "sponsor_name": "RISING",
      "openfda": {
        "application_number": [
          "ANDA073393"
        ],
        "brand_name": [
          "TOLMETIN SODIUM"
        ],
        "generic_name": [
          "TOLMETIN SODIUM"
        ],
        "manufacturer_name": [
          "Atland Pharmaceuticals, LLC",
          "Galt Pharmaceuticals, LLC",
          "Rising Pharma Holdings, Inc."
        ],
        "product_ndc": [
          "71993-309",
          "61825-310",
          "16571-826"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "TOLMETIN SODIUM"
        ],
        "rxcui": [
          "198296"
        ],
        "spl_id": [
          "abeefa75-1276-43da-b344-90d478c022fc",
          "4d9de430-f193-a927-e063-6294a90a14d4",
          "a6175635-172e-4b9e-8388-b60c2aa117a2"
        ],
        "spl_set_id": [
          "41b7704e-25a1-45e8-93c0-9ac2f0effef9",
          "0a97800f-706d-4787-98fe-08dadf9c4d5f",
          "740a0f37-aa95-4558-b415-be516b8c40a3"
        ],
        "package_ndc": [
          "71993-309-30",
          "61825-310-30",
          "16571-826-09"
        ],
        "unii": [
          "02N1TZF99F"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "TOLMETIN SODIUM",
          "active_ingredients": [
            {
              "name": "TOLMETIN SODIUM",
              "strength": "EQ 400MG BASE"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "CAPSULE",
          "route": "ORAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}