{
  "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": "1",
          "submission_status": "AP",
          "submission_status_date": "19930317",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20020417",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "19970516",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "19950630",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "19930726",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19920817",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "19970728",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "19950207",
          "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": "19950106",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "NDA020208",
      "sponsor_name": "BAUSCH",
      "openfda": {
        "application_number": [
          "NDA020208"
        ],
        "brand_name": [
          "METRONIDAZOLE"
        ],
        "generic_name": [
          "METRONIDAZOLE"
        ],
        "manufacturer_name": [
          "Oceanside Pharmaceuticals"
        ],
        "product_ndc": [
          "68682-455"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "VAGINAL"
        ],
        "substance_name": [
          "METRONIDAZOLE"
        ],
        "rxcui": [
          "142046"
        ],
        "spl_id": [
          "25ae84b0-f8f3-41c3-b5ff-477624171706"
        ],
        "spl_set_id": [
          "526c226a-099b-4eb3-943d-c88b2763b2c1"
        ],
        "package_ndc": [
          "68682-455-70"
        ],
        "nui": [
          "N0000175435",
          "M0014907"
        ],
        "pharm_class_epc": [
          "Nitroimidazole Antimicrobial [EPC]"
        ],
        "pharm_class_cs": [
          "Nitroimidazoles [CS]"
        ],
        "unii": [
          "140QMO216E"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "METROGEL-VAGINAL",
          "active_ingredients": [
            {
              "name": "METRONIDAZOLE",
              "strength": "0.75%"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "GEL",
          "route": "VAGINAL",
          "marketing_status": "Discontinued",
          "te_code": "AB"
        }
      ]
    }
  ]
}