{
  "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": "2026-07-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20250716",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 5",
          "submission_class_code_description": "Type 5 - New Formulation or New Manufacturer",
          "application_docs": [
            {
              "id": "82888",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/219935Orig1s000ltr.pdf",
              "date": "20250717",
              "type": "Letter"
            },
            {
              "id": "82900",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219935s000lbl.pdf",
              "date": "20250721",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA219935",
      "sponsor_name": "SAGENT",
      "openfda": {
        "application_number": [
          "NDA219935"
        ],
        "brand_name": [
          "FAMOTIDINE"
        ],
        "generic_name": [
          "FAMOTIDINE"
        ],
        "manufacturer_name": [
          "Sagent Pharmaceuticals"
        ],
        "product_ndc": [
          "25021-755",
          "25021-756"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "FAMOTIDINE"
        ],
        "rxcui": [
          "2727402",
          "2727403"
        ],
        "spl_id": [
          "8fa9902c-ea0d-489f-99dc-d47cb615d471"
        ],
        "spl_set_id": [
          "9710995d-b518-40ce-bc2b-8b5dcf002c31"
        ],
        "package_ndc": [
          "25021-755-05",
          "25021-756-10",
          "25021-756-50"
        ],
        "nui": [
          "N0000000151",
          "N0000175784"
        ],
        "pharm_class_moa": [
          "Histamine H2 Receptor Antagonists [MoA]"
        ],
        "pharm_class_epc": [
          "Histamine-2 Receptor Antagonist [EPC]"
        ],
        "unii": [
          "5QZO15J2Z8"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "FAMOTIDINE",
          "active_ingredients": [
            {
              "name": "FAMOTIDINE",
              "strength": "20MG/5ML (4MG/ML)"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SOLUTION",
          "route": "INTRAVENOUS",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "FAMOTIDINE",
          "active_ingredients": [
            {
              "name": "FAMOTIDINE",
              "strength": "40MG/10ML (4MG/ML)"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SOLUTION",
          "route": "INTRAVENOUS",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "FAMOTIDINE",
          "active_ingredients": [
            {
              "name": "FAMOTIDINE",
              "strength": "200MG/50ML (4MG/ML)"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SOLUTION",
          "route": "INTRAVENOUS",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}