{
  "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": "20220131",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 2/3",
          "submission_class_code_description": "Type 2 - New Active Ingredient and Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "70042",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215428Orig1s000ltr.pdf",
              "date": "20220201",
              "type": "Letter"
            },
            {
              "id": "70056",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215428s000lbl.pdf",
              "date": "20220203",
              "type": "Label"
            },
            {
              "id": "72479",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/215428Orig1s000TOC.html",
              "date": "20221026",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20230818",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "75188",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215428s002lbl.pdf",
              "date": "20230818",
              "type": "Label"
            },
            {
              "id": "75189",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215428s002lbl.pdf#page=24",
              "date": "20230821",
              "type": "Medication Guide"
            },
            {
              "id": "75248",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215428Orig1s002,215133Orig1s001ltr.pdf",
              "date": "20230822",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA215428",
      "sponsor_name": "ALMATICA",
      "openfda": {
        "application_number": [
          "NDA215428"
        ],
        "brand_name": [
          "CITALOPRAM"
        ],
        "generic_name": [
          "CITALOPRAM"
        ],
        "manufacturer_name": [
          "Almatica Pharma LLC"
        ],
        "product_ndc": [
          "52427-691"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CITALOPRAM HYDROBROMIDE"
        ],
        "rxcui": [
          "2591786"
        ],
        "spl_id": [
          "0bb9dfa0-f842-cf8c-cc79-79a14d75d446"
        ],
        "spl_set_id": [
          "2f815b0c-6da7-cb61-e89c-7de628092d0d"
        ],
        "package_ndc": [
          "52427-691-30"
        ],
        "unii": [
          "I1E9D14F36"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "CITALOPRAM HYDROBROMIDE",
          "active_ingredients": [
            {
              "name": "CITALOPRAM HYDROBROMIDE",
              "strength": "EQ 30MG BASE"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "CAPSULE",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}