{
  "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": "43",
          "submission_status": "AP",
          "submission_status_date": "20181102",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "19940804",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "19880505",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "19930209",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "20000406",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "19920511",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "19860114",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20090930"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "52",
          "submission_status": "AP",
          "submission_status_date": "20250627",
          "review_priority": "UNKNOWN",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "83014",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/088389Orig1s052; 088390s062lbl.pdf",
              "date": "20250801",
              "type": "Label"
            },
            {
              "id": "83017",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/088389Orig1s052; 088390Orig1s062ltr.pdf",
              "date": "20250801",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "36",
          "submission_status": "AP",
          "submission_status_date": "20170728",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "28",
          "submission_status": "AP",
          "submission_status_date": "20041004",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "19960304",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "32",
          "submission_status": "AP",
          "submission_status_date": "20070629",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "19930323",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "22",
          "submission_status": "AP",
          "submission_status_date": "20000406",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "19870608",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "19920512",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "19870316",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "19920127",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "47",
          "submission_status": "AP",
          "submission_status_date": "20210608",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "ANDA088389",
      "sponsor_name": "DEPROCO",
      "openfda": {
        "application_number": [
          "ANDA088389"
        ],
        "brand_name": [
          "LIDOCAINE",
          "XYLOCAINE",
          "LIGNOSPAN FORTE"
        ],
        "generic_name": [
          "LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE",
          "LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE"
        ],
        "manufacturer_name": [
          "Benco Dental",
          "Dentsply Pharmaceutical",
          "Septodont, Inc.",
          "Henry Schein Inc.",
          "Darby Dental Supply, LLC",
          "Patterson Dental"
        ],
        "product_ndc": [
          "66975-415",
          "66312-181",
          "66312-176",
          "0362-0262",
          "0404-6500",
          "66467-9710",
          "50227-1020",
          "0362-1096"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBMUCOSAL"
        ],
        "substance_name": [
          "EPINEPHRINE BITARTRATE",
          "LIDOCAINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1657026",
          "1010768",
          "1293648",
          "1608499",
          "1011814"
        ],
        "spl_id": [
          "a1eda120-03b1-4822-b40d-0a92d97109b9",
          "5b7b5a3e-e9fe-4dd1-949f-d3cac9755bb5",
          "70fc8bb8-829f-4021-b450-9a65c3ddd3ce",
          "b055228e-5fe9-4d8b-825d-46c4a23d4f19",
          "adf7d4fa-55d8-43d3-ab50-11f6cebeda1b",
          "3a44f314-abf0-41c6-8154-5feceae1f738",
          "cb2397ba-49a9-4c95-bbde-17d1260607ee"
        ],
        "spl_set_id": [
          "9419ac39-9b26-4cca-a2d6-167205fede24",
          "14b55cf9-f7cd-4bb4-a7c5-aba61abadef1",
          "df130310-41db-45df-a214-9da01cf0bf41",
          "1ca96c77-d983-496b-84a6-54709e80f532",
          "27e8fdfb-e923-4f99-aff7-8b9e50228151",
          "f074c0dc-7c3f-46fd-a480-b8337a19fe5c",
          "f8ca7d03-01c8-450f-9279-59789c3497ea"
        ],
        "package_ndc": [
          "66975-415-51",
          "66312-181-16",
          "66312-176-16",
          "0362-0262-05",
          "0404-6500-15",
          "66467-9710-5",
          "50227-1020-5",
          "0362-1096-70"
        ],
        "unii": [
          "30Q7KI53AK",
          "V13007Z41A"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "LIGNOSPAN FORTE",
          "active_ingredients": [
            {
              "name": "EPINEPHRINE BITARTRATE",
              "strength": "EQ 0.02MG BASE/ML"
            },
            {
              "name": "LIDOCAINE HYDROCHLORIDE",
              "strength": "2%"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}