{
  "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": "2",
          "submission_status": "AP",
          "submission_status_date": "20160916",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20150821",
          "submission_class_code": "UNKNOWN"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20240716",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20190918",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20190918",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "ANDA204519",
      "sponsor_name": "ALEMBIC",
      "openfda": {
        "application_number": [
          "ANDA204519"
        ],
        "brand_name": [
          "CELECOXIB"
        ],
        "generic_name": [
          "CELECOXIB"
        ],
        "manufacturer_name": [
          "Alembic Pharmaceuticals Inc.",
          "Alembic Pharmaceuticals Limited"
        ],
        "product_ndc": [
          "62332-140",
          "62332-141",
          "62332-142",
          "62332-143",
          "46708-267",
          "46708-268",
          "46708-269",
          "46708-270"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CELECOXIB"
        ],
        "rxcui": [
          "205322",
          "205323",
          "349514",
          "686379"
        ],
        "spl_id": [
          "0ae26abe-bbc0-48bf-b038-ca400ee197cd",
          "c884ffd4-3a40-48a1-99b6-73b1ef9324b4"
        ],
        "spl_set_id": [
          "806e5f8a-f986-4f88-ba3e-8265f86afa48",
          "14e8d788-e44c-4a40-8678-25cf45fed477"
        ],
        "package_ndc": [
          "62332-140-30",
          "62332-140-60",
          "62332-140-91",
          "62332-140-08",
          "62332-141-30",
          "62332-141-31",
          "62332-141-91",
          "62332-141-08",
          "62332-141-60",
          "62332-141-71",
          "62332-142-30",
          "62332-142-31",
          "62332-142-91",
          "62332-142-71",
          "62332-142-08",
          "62332-142-60",
          "62332-143-30",
          "62332-143-60",
          "62332-143-71",
          "62332-143-10",
          "46708-267-30",
          "46708-267-60",
          "46708-267-91",
          "46708-267-12",
          "46708-268-30",
          "46708-268-31",
          "46708-268-91",
          "46708-268-12",
          "46708-268-60",
          "46708-268-71",
          "46708-269-30",
          "46708-269-31",
          "46708-269-71",
          "46708-269-91",
          "46708-269-12",
          "46708-269-60",
          "46708-270-30",
          "46708-270-60",
          "46708-270-71",
          "46708-270-10"
        ],
        "nui": [
          "N0000000160",
          "M0001335",
          "N0000175722"
        ],
        "pharm_class_moa": [
          "Cyclooxygenase Inhibitors [MoA]"
        ],
        "pharm_class_cs": [
          "Anti-Inflammatory Agents, Non-Steroidal [CS]"
        ],
        "pharm_class_epc": [
          "Nonsteroidal Anti-inflammatory Drug [EPC]"
        ],
        "unii": [
          "JCX84Q7J1L"
        ]
      },
      "products": [
        {
          "product_number": "003",
          "reference_drug": "No",
          "brand_name": "CELECOXIB",
          "active_ingredients": [
            {
              "name": "CELECOXIB",
              "strength": "200MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "CELECOXIB",
          "active_ingredients": [
            {
              "name": "CELECOXIB",
              "strength": "50MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "004",
          "reference_drug": "No",
          "brand_name": "CELECOXIB",
          "active_ingredients": [
            {
              "name": "CELECOXIB",
              "strength": "400MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "CELECOXIB",
          "active_ingredients": [
            {
              "name": "CELECOXIB",
              "strength": "100MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}