{
  "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": "1",
          "submission_status": "AP",
          "submission_status_date": "20200209",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20221007",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20200718",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20190419",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20221007",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "ANDA209572",
      "sponsor_name": "ALEMBIC",
      "openfda": {
        "application_number": [
          "ANDA209572"
        ],
        "brand_name": [
          "TERIFLUNOMIDE"
        ],
        "generic_name": [
          "TERIFLUNOMIDE"
        ],
        "manufacturer_name": [
          "Alembic Pharmaceuticals Inc.",
          "Alembic Pharmaceuticals Limited"
        ],
        "product_ndc": [
          "62332-313",
          "62332-314",
          "46708-313",
          "46708-314"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "TERIFLUNOMIDE"
        ],
        "spl_id": [
          "95e1ed70-9c5b-4bad-a26e-b33cd3f9b7ee",
          "5c2a05ed-ff36-4dce-97e9-77b2d948b4f0"
        ],
        "spl_set_id": [
          "8c1bc23b-a62b-4172-a603-8b97761514b4",
          "2b084b44-f15b-4b16-b700-4382434f2136"
        ],
        "package_ndc": [
          "62332-313-14",
          "62332-313-30",
          "62332-314-14",
          "62332-314-30",
          "62332-314-91",
          "46708-313-14",
          "46708-313-30",
          "46708-314-14",
          "46708-314-30",
          "46708-314-91"
        ],
        "nui": [
          "N0000185502",
          "N0000185501"
        ],
        "pharm_class_epc": [
          "Pyrimidine Synthesis Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Dihydroorotate Dehydrogenase Inhibitors [MoA]"
        ],
        "unii": [
          "1C058IKG3B"
        ],
        "rxcui": [
          "1310525",
          "1310533"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "TERIFLUNOMIDE",
          "active_ingredients": [
            {
              "name": "TERIFLUNOMIDE",
              "strength": "7MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "TERIFLUNOMIDE",
          "active_ingredients": [
            {
              "name": "TERIFLUNOMIDE",
              "strength": "14MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}