{
  "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": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20191226",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN",
          "application_docs": [
            {
              "id": "62180",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211908Orig1s000ltr.pdf",
              "date": "20200317",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20251009",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20210202",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20230808",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20210202",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "ANDA211908",
      "sponsor_name": "GLAND",
      "openfda": {
        "application_number": [
          "ANDA211908"
        ],
        "brand_name": [
          "ZIPRASIDONE MESYLATE"
        ],
        "generic_name": [
          "ZIPRASIDONE MESYLATE"
        ],
        "manufacturer_name": [
          "Fosun Pharma USA Inc.",
          "Dr.Reddy's Laboratories, Inc.",
          "Gland Pharma Limited"
        ],
        "product_ndc": [
          "72266-160",
          "43598-848",
          "68083-340",
          "43598-061"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR"
        ],
        "substance_name": [
          "ZIPRASIDONE MESYLATE"
        ],
        "rxcui": [
          "351223"
        ],
        "spl_id": [
          "3154a481-cab5-d000-e063-6294a90a64bd",
          "44d8fcde-2e03-b6e8-d5dd-d062e075be8c",
          "3154c525-bdf4-07a9-e063-6294a90a607a",
          "dae5d774-0982-4b2b-8803-02bd0910d228",
          "b94a787b-0592-ac3d-b887-c706d571f6e8"
        ],
        "spl_set_id": [
          "b28a4f3d-0aae-050d-e053-2995a90aa4a6",
          "3cb79985-1207-602e-2dda-a118133b4c60",
          "90f55022-8d58-4bfb-9464-9bf11395ae17",
          "77a10f48-e300-465f-81b5-54be38daa4b3",
          "6fd6fc45-20c4-e223-3532-ce37aa02b71c"
        ],
        "package_ndc": [
          "72266-160-41",
          "72266-160-42",
          "43598-848-58",
          "72266-160-01",
          "72266-160-10",
          "68083-340-01",
          "43598-061-11",
          "43598-061-58"
        ],
        "unii": [
          "3X6SAX83JZ"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "ZIPRASIDONE MESYLATE",
          "active_ingredients": [
            {
              "name": "ZIPRASIDONE MESYLATE",
              "strength": "EQ 20MG BASE/VIAL"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "POWDER",
          "route": "INTRAMUSCULAR",
          "marketing_status": "Prescription",
          "te_code": "AP"
        }
      ]
    }
  ]
}