{
  "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": "2",
          "submission_status": "AP",
          "submission_status_date": "20220922",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20220922",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20190626",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20250221",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "ANDA212231",
      "sponsor_name": "SOMERSET",
      "openfda": {
        "application_number": [
          "ANDA212231"
        ],
        "brand_name": [
          "SULFAMETHOXAZOLE AND TRIMETHOPRIM"
        ],
        "generic_name": [
          "SULFAMETHOXAZOLE AND TRIMETHOPRIM"
        ],
        "manufacturer_name": [
          "Somerset Therapeutics, LLC"
        ],
        "product_ndc": [
          "70069-361",
          "70069-362",
          "70069-363"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "SULFAMETHOXAZOLE",
          "TRIMETHOPRIM"
        ],
        "rxcui": [
          "313137",
          "1809083"
        ],
        "spl_id": [
          "012dfac7-9b72-48a5-a364-e62bbe150cfe"
        ],
        "spl_set_id": [
          "ebb570bb-6e5e-489e-875c-9e7b3a6d716a"
        ],
        "package_ndc": [
          "70069-361-01",
          "70069-361-10",
          "70069-362-01",
          "70069-362-10",
          "70069-363-01"
        ],
        "nui": [
          "N0000175504",
          "M0020790",
          "N0000185504",
          "N0000175489",
          "N0000000191",
          "N0000187062",
          "N0000187061"
        ],
        "pharm_class_epc": [
          "Sulfonamide Antimicrobial [EPC]",
          "Dihydrofolate Reductase Inhibitor Antibacterial [EPC]"
        ],
        "pharm_class_cs": [
          "Sulfonamides [CS]"
        ],
        "pharm_class_moa": [
          "Cytochrome P450 2C9 Inhibitors [MoA]",
          "Dihydrofolate Reductase Inhibitors [MoA]",
          "Cytochrome P450 2C8 Inhibitors [MoA]",
          "Organic Cation Transporter 2 Inhibitors [MoA]"
        ],
        "unii": [
          "JE42381TNV",
          "AN164J8Y0X"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "SULFAMETHOXAZOLE AND TRIMETHOPRIM",
          "active_ingredients": [
            {
              "name": "SULFAMETHOXAZOLE",
              "strength": "80MG/ML"
            },
            {
              "name": "TRIMETHOPRIM",
              "strength": "16MG/ML"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        }
      ]
    }
  ]
}