{
  "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": "2026-06-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 209
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20251202",
          "submission_class_code": "UNKNOWN",
          "application_docs": [
            {
              "id": "84745",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/202388Orig1s000ltr.pdf",
              "date": "20260113",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "ANDA202388",
      "sponsor_name": "SANDOZ",
      "openfda": {
        "application_number": [
          "ANDA202388"
        ],
        "brand_name": [
          "SITAGLIPTIN AND METFORMIN HYDROCHLORIDE"
        ],
        "generic_name": [
          "SITAGLIPTIN AND METFORMIN HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Sandoz Inc"
        ],
        "product_ndc": [
          "0781-5801",
          "0781-5802"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "METFORMIN HYDROCHLORIDE",
          "SITAGLIPTIN PHOSPHATE"
        ],
        "rxcui": [
          "2709488",
          "2709491"
        ],
        "spl_id": [
          "a0fcdc08-0afc-4912-a126-3efea6bc8c61"
        ],
        "spl_set_id": [
          "a0fcdc08-0afc-4912-a126-3efea6bc8c61"
        ],
        "package_ndc": [
          "0781-5801-60",
          "0781-5801-71",
          "0781-5801-05",
          "0781-5802-60",
          "0781-5802-71",
          "0781-5802-73"
        ],
        "unii": [
          "786Z46389E",
          "TS63EW8X6F"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "SITAGLIPTIN AND METFORMIN HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "METFORMIN HYDROCHLORIDE",
              "strength": "500MG"
            },
            {
              "name": "SITAGLIPTIN PHOSPHATE",
              "strength": "EQ 50MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "SITAGLIPTIN AND METFORMIN HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "METFORMIN HYDROCHLORIDE",
              "strength": "1GM"
            },
            {
              "name": "SITAGLIPTIN PHOSPHATE",
              "strength": "EQ 50MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}