{
  "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": "20210826",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20230717",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20230717",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "ANDA215414",
      "sponsor_name": "ASCENT PHARMS INC",
      "openfda": {
        "application_number": [
          "ANDA215414"
        ],
        "brand_name": [
          "TOPIRAMATE"
        ],
        "generic_name": [
          "TOPIRAMATE"
        ],
        "manufacturer_name": [
          "Camber Pharmaceuticals, Inc.",
          "XLCare Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "31722-181",
          "31722-182",
          "31722-183",
          "31722-184",
          "72865-313",
          "72865-314",
          "72865-315",
          "72865-316"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "TOPIRAMATE"
        ],
        "rxcui": [
          "151226",
          "199888",
          "199889",
          "199890"
        ],
        "spl_id": [
          "62911647-4208-47b3-a9af-67f026411019",
          "297988b4-69fb-4691-92e0-ee5da80b0125"
        ],
        "spl_set_id": [
          "cefbc5f4-ef5f-4732-ab96-a69a183f0b6b",
          "546103e1-ea6e-466b-b0de-b1ff8c494512"
        ],
        "package_ndc": [
          "31722-181-60",
          "31722-181-05",
          "31722-182-60",
          "31722-182-05",
          "31722-183-60",
          "31722-183-05",
          "31722-184-60",
          "31722-184-05",
          "72865-313-60",
          "72865-313-10",
          "72865-314-60",
          "72865-314-10",
          "72865-315-60",
          "72865-315-10",
          "72865-316-60",
          "72865-316-10"
        ],
        "nui": [
          "N0000008486",
          "N0000185506",
          "N0000182140"
        ],
        "pharm_class_pe": [
          "Decreased Central Nervous System Disorganized Electrical Activity [PE]"
        ],
        "pharm_class_moa": [
          "Cytochrome P450 3A4 Inducers [MoA]",
          "Cytochrome P450 2C19 Inhibitors [MoA]"
        ],
        "unii": [
          "0H73WJJ391"
        ]
      },
      "products": [
        {
          "product_number": "003",
          "reference_drug": "No",
          "brand_name": "TOPIRAMATE",
          "active_ingredients": [
            {
              "name": "TOPIRAMATE",
              "strength": "100MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "TOPIRAMATE",
          "active_ingredients": [
            {
              "name": "TOPIRAMATE",
              "strength": "25MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "004",
          "reference_drug": "No",
          "brand_name": "TOPIRAMATE",
          "active_ingredients": [
            {
              "name": "TOPIRAMATE",
              "strength": "200MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "TOPIRAMATE",
          "active_ingredients": [
            {
              "name": "TOPIRAMATE",
              "strength": "50MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}