{
  "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": "2026-09-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 9
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20240725",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN"
        }
      ],
      "application_number": "ANDA216041",
      "sponsor_name": "AUROBINDO PHARMA LTD",
      "openfda": {
        "application_number": [
          "ANDA216041"
        ],
        "brand_name": [
          "DOXEPIN"
        ],
        "generic_name": [
          "DOXEPIN"
        ],
        "manufacturer_name": [
          "Aurobindo Pharma Limited",
          "NorthStar Rx LLC"
        ],
        "product_ndc": [
          "59651-844",
          "59651-845",
          "72603-919",
          "72603-920"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DOXEPIN HYDROCHLORIDE"
        ],
        "rxcui": [
          "966787",
          "966793"
        ],
        "spl_id": [
          "29b3bf98-2c57-4d87-b5eb-5232e46dc639",
          "77782f36-d120-4c3d-bebd-c8b0f4749d98"
        ],
        "spl_set_id": [
          "29b3bf98-2c57-4d87-b5eb-5232e46dc639",
          "77782f36-d120-4c3d-bebd-c8b0f4749d98"
        ],
        "package_ndc": [
          "59651-844-30",
          "59651-845-30",
          "72603-919-01",
          "72603-920-01"
        ],
        "unii": [
          "3U9A0FE9N5"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "DOXEPIN HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "DOXEPIN HYDROCHLORIDE",
              "strength": "EQ 6MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "DOXEPIN HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "DOXEPIN HYDROCHLORIDE",
              "strength": "EQ 3MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}