{
  "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": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20230817",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20230816",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20180709",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20230817",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20230817",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "ANDA208987",
      "sponsor_name": "SUNSHINE",
      "openfda": {
        "application_number": [
          "ANDA208987"
        ],
        "brand_name": [
          "CLARITHROMYCIN"
        ],
        "generic_name": [
          "CLARITHROMYCIN"
        ],
        "manufacturer_name": [
          "Lannett Company, Inc.",
          "Solaris Pharma Corporation",
          "Chartwell RX, LLC"
        ],
        "product_ndc": [
          "0527-1930",
          "73473-911",
          "62135-883"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CLARITHROMYCIN"
        ],
        "rxcui": [
          "359385"
        ],
        "spl_id": [
          "05ef280b-60a9-77ec-e063-6394a90a7821",
          "4d4303a8-74ef-6e98-e063-6394a90a47d6",
          "459c547f-8c37-1425-e063-6394a90a48e6"
        ],
        "spl_set_id": [
          "71a836d0-d60f-6418-e053-2a95a90aa6ef",
          "4d4303f8-88dd-8b88-e063-6394a90ab48f",
          "dea5bd78-7f93-4bc4-a2e4-1b021f5fe098"
        ],
        "package_ndc": [
          "0527-1930-06",
          "73473-911-60",
          "62135-883-60"
        ],
        "nui": [
          "N0000175935",
          "M0028311",
          "N0000182141",
          "N0000190114",
          "N0000185503"
        ],
        "pharm_class_epc": [
          "Macrolide Antimicrobial [EPC]"
        ],
        "pharm_class_cs": [
          "Macrolides [CS]"
        ],
        "pharm_class_moa": [
          "Cytochrome P450 3A4 Inhibitors [MoA]",
          "Cytochrome P450 3A Inhibitors [MoA]",
          "P-Glycoprotein Inhibitors [MoA]"
        ],
        "unii": [
          "H1250JIK0A"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "CLARITHROMYCIN",
          "active_ingredients": [
            {
              "name": "CLARITHROMYCIN",
              "strength": "500MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET, EXTENDED RELEASE",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}