{
  "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": "6",
          "submission_status": "AP",
          "submission_status_date": "20130510",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20180403",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "53611",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022308s013lbl.pdf",
              "date": "20180405",
              "type": "Label"
            },
            {
              "id": "53612",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022308s013ltr.pdf",
              "date": "20180405",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20151110",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20140905",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20131114",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20130816",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20120918",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "38547",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022308s003lbl.pdf",
              "date": "20120920",
              "type": "Label"
            },
            {
              "id": "29567",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022308Orig1s003ltr.pdf",
              "date": "20120924",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20150407",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20090528",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "38546",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022308lbl.pdf",
              "date": "20090604",
              "type": "Label"
            },
            {
              "id": "42486",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022308s000TOC.html",
              "date": "20090710",
              "type": "Review"
            },
            {
              "id": "44734",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022308s000_SumR.pdf",
              "date": "20090710",
              "type": "Summary Review"
            },
            {
              "id": "53193",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022308s000_Besifloxacin hydrochloride_Clinical_PREA.pdf",
              "date": "19000101",
              "type": "Pediatric Medical Review"
            },
            {
              "id": "53194",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022308s000_Besifloxacin hydrochloride_ClinPharm_PREA.pdf",
              "date": "19000101",
              "type": "Pediatric Clinical Pharmacology Review"
            },
            {
              "id": "53195",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022308s000_Besifloxacin hydrochloride_Statistical_PREA.pdf",
              "date": "19000101",
              "type": "Pediatric Statistical Review"
            },
            {
              "id": "7211",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022308s000ltr.pdf",
              "date": "20090602",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20140430",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        }
      ],
      "application_number": "NDA022308",
      "sponsor_name": "BAUSCH AND LOMB",
      "openfda": {
        "application_number": [
          "NDA022308"
        ],
        "brand_name": [
          "BESIVANCE"
        ],
        "generic_name": [
          "BESIFLOXACIN"
        ],
        "manufacturer_name": [
          "Bausch & Lomb Americas Inc.",
          "Bausch & Lomb Incorporated"
        ],
        "product_ndc": [
          "82260-466",
          "24208-446"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "BESIFLOXACIN"
        ],
        "spl_id": [
          "483360bc-332c-6ccd-e063-6394a90a0b25",
          "1c4756f2-d92f-af5d-e063-6294a90a9a49"
        ],
        "spl_set_id": [
          "ff971287-5610-4f15-8392-fc974e6ff646",
          "a3e6d688-7e5e-4ca3-b27e-79756c322a32"
        ],
        "package_ndc": [
          "82260-466-05",
          "24208-446-05",
          "24208-446-02"
        ],
        "nui": [
          "N0000175937",
          "M0023650"
        ],
        "pharm_class_epc": [
          "Quinolone Antimicrobial [EPC]"
        ],
        "pharm_class_cs": [
          "Quinolones [CS]"
        ],
        "unii": [
          "BFE2NBZ7NX"
        ],
        "rxcui": [
          "850305",
          "850309"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "BESIVANCE",
          "active_ingredients": [
            {
              "name": "BESIFLOXACIN HYDROCHLORIDE",
              "strength": "EQ 0.6% BASE"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SUSPENSION/DROPS",
          "route": "OPHTHALMIC",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}