{
  "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": "7",
          "submission_status": "AP",
          "submission_status_date": "20220824",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20220824",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20220824",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20130430",
          "submission_class_code": "UNKNOWN"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20220824",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20220824",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20220824",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "ANDA202409",
      "sponsor_name": "AUROBINDO PHARMA LTD",
      "openfda": {
        "application_number": [
          "ANDA202409"
        ],
        "brand_name": [
          "CLINDAMYCIN PALMITATE HYDROCHLORIDE (PEDIATRIC)"
        ],
        "generic_name": [
          "CLINDAMYCIN PALMITATE HYDROCHLORIDE (PEDIATRIC)"
        ],
        "manufacturer_name": [
          "Aurobindo Pharma Limited",
          "NorthStar Rx LLC"
        ],
        "product_ndc": [
          "65862-596",
          "16714-483"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CLINDAMYCIN PALMITATE HYDROCHLORIDE"
        ],
        "rxcui": [
          "562266"
        ],
        "spl_id": [
          "78e0ae1e-9c06-4831-b962-e1aa65546110",
          "366c8a71-1c5c-47e8-989d-d04503c65f4b"
        ],
        "spl_set_id": [
          "0bfe1e25-f0a1-4e11-9827-82912557c46b",
          "b35e3714-44d1-4e6a-a124-555ad259fec1"
        ],
        "package_ndc": [
          "65862-596-01",
          "65862-596-02",
          "16714-483-01",
          "16714-483-02"
        ],
        "unii": [
          "VN9A8JM7M7"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "CLINDAMYCIN PALMITATE HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "CLINDAMYCIN PALMITATE HYDROCHLORIDE",
              "strength": "EQ 75MG BASE/5ML"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "FOR SOLUTION",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AA"
        }
      ]
    }
  ]
}