{
  "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": "20200729",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20220902",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "ANDA210579",
      "sponsor_name": "MISEMER",
      "openfda": {
        "application_number": [
          "ANDA210579"
        ],
        "brand_name": [
          "CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE"
        ],
        "generic_name": [
          "CHLORDIAZEPOXIDE HYDROCHLORIDE, CLIDINIUM BROMIDE"
        ],
        "manufacturer_name": [
          "Misemer Pharmaceuticals, Inc"
        ],
        "product_ndc": [
          "0276-0500"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CHLORDIAZEPOXIDE HYDROCHLORIDE",
          "CLIDINIUM BROMIDE"
        ],
        "rxcui": [
          "889614"
        ],
        "spl_id": [
          "4139e8c6-5256-6934-e063-6294a90aa5a0"
        ],
        "spl_set_id": [
          "a42fc981-77bc-4c9e-a79d-b821bffb65b4"
        ],
        "package_ndc": [
          "0276-0500-10"
        ],
        "unii": [
          "MFM6K1XWDK",
          "91ZQW5JF1Z"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE",
          "active_ingredients": [
            {
              "name": "CHLORDIAZEPOXIDE HYDROCHLORIDE",
              "strength": "5MG"
            },
            {
              "name": "CLIDINIUM BROMIDE",
              "strength": "2.5MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}