{
  "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": "20120629",
          "submission_class_code": "N/A",
          "submission_class_code_description": "Not Applicable"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20130510",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20231215",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20231205",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20180626",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20170113",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20251229",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20180628",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20170829",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "ANDA200386",
      "sponsor_name": "COSETTE",
      "openfda": {
        "application_number": [
          "ANDA200386"
        ],
        "brand_name": [
          "PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE"
        ],
        "generic_name": [
          "PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE"
        ],
        "manufacturer_name": [
          "Cosette Pharmaceuticals, Inc.",
          "Cranbury Pharmaceuticals, LLC"
        ],
        "product_ndc": [
          "0713-0823",
          "27808-065"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CODEINE PHOSPHATE",
          "PROMETHAZINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "991486"
        ],
        "spl_id": [
          "ad6f539c-d968-4a3b-9550-ab7e78bee74c",
          "981526cb-82c9-4a44-a891-7c44c708163e"
        ],
        "spl_set_id": [
          "3b02cda4-9b24-79c9-e063-6294a90af5b9",
          "785c605e-1907-4fac-8b69-d504a2076f8e"
        ],
        "package_ndc": [
          "0713-0823-75",
          "27808-065-02",
          "27808-065-01"
        ],
        "unii": [
          "GSL05Y1MN6",
          "R61ZEH7I1I"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE",
          "active_ingredients": [
            {
              "name": "CODEINE PHOSPHATE",
              "strength": "10MG/5ML"
            },
            {
              "name": "PROMETHAZINE HYDROCHLORIDE",
              "strength": "6.25MG/5ML"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SYRUP",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AA"
        }
      ]
    }
  ]
}