{
  "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": "8",
          "submission_status": "AP",
          "submission_status_date": "20170427",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20230117",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20110504"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20170717",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20170427",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "ANDA090316",
      "sponsor_name": "ONESOURCE SPECIALTY",
      "openfda": {
        "application_number": [
          "ANDA090316"
        ],
        "brand_name": [
          "MIDAZOLAM"
        ],
        "generic_name": [
          "MIDAZOLAM HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "SOMERSET THERAPEUTICS, LLC",
          "Steriscience Specialties Private Limited"
        ],
        "product_ndc": [
          "70069-818",
          "82449-207",
          "82449-208",
          "82449-209"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "MIDAZOLAM HYDROCHLORIDE"
        ],
        "rxcui": [
          "311702",
          "311700"
        ],
        "spl_id": [
          "0bbe7c1c-5228-e584-e063-6294a90ad750",
          "0c638f3c-bdd6-8385-e063-6394a90a53ef"
        ],
        "spl_set_id": [
          "06e4f754-72df-4eb4-aaed-b538524f5277",
          "473fba4b-8754-4b1d-bba9-d9c8f6d818e0"
        ],
        "package_ndc": [
          "70069-818-10",
          "82449-207-02",
          "82449-208-02",
          "82449-209-02"
        ],
        "unii": [
          "W7TTW573JJ"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "MIDOZALAM HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "MIDAZOLAM HYDROCHLORIDE",
              "strength": "EQ 1MG BASE/ML"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        },
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "MIDOZALAM HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "MIDAZOLAM HYDROCHLORIDE",
              "strength": "EQ 5MG BASE/ML"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        }
      ]
    }
  ]
}