{
  "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": "3",
          "submission_status": "AP",
          "submission_status_date": "20000204",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "26",
          "submission_status": "AP",
          "submission_status_date": "20150527",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20000421",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "24",
          "submission_status": "AP",
          "submission_status_date": "20120514",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19990930",
          "application_docs": [
            {
              "id": "18387",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-091_Carbidopa%20and%20Levodopa_prntlbl.pdf",
              "date": "19990930",
              "type": "Label"
            },
            {
              "id": "22416",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-091_Carbidopa.html",
              "date": "19990930",
              "type": "Review"
            },
            {
              "id": "30753",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75091ta.pdf",
              "date": "20040624",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20021001",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20011107",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20000811",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20000421",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20020612",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20000811",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        }
      ],
      "application_number": "ANDA075091",
      "sponsor_name": "MYLAN",
      "openfda": {
        "application_number": [
          "ANDA075091"
        ],
        "brand_name": [
          "CARBIDOPA AND LEVODOPA"
        ],
        "generic_name": [
          "CARBIDOPA AND LEVODOPA"
        ],
        "manufacturer_name": [
          "Mylan Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "0378-0088",
          "0378-0094"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CARBIDOPA",
          "LEVODOPA"
        ],
        "spl_id": [
          "164375a9-db50-4cb3-86ca-a52a3e74cc83"
        ],
        "spl_set_id": [
          "aa5028d6-fd0a-4cf1-b708-c93bb2a7c76a"
        ],
        "package_ndc": [
          "0378-0088-01",
          "0378-0094-01"
        ],
        "nui": [
          "N0000193220",
          "M0370111",
          "N0000175754",
          "N0000175755"
        ],
        "pharm_class_epc": [
          "Aromatic Amino Acid [EPC]",
          "Aromatic Amino Acid Decarboxylation Inhibitor [EPC]"
        ],
        "pharm_class_cs": [
          "Amino Acids, Aromatic [CS]"
        ],
        "pharm_class_moa": [
          "DOPA Decarboxylase Inhibitors [MoA]"
        ],
        "unii": [
          "46627O600J",
          "MNX7R8C5VO"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "CARBIDOPA AND LEVODOPA",
          "active_ingredients": [
            {
              "name": "CARBIDOPA",
              "strength": "25MG"
            },
            {
              "name": "LEVODOPA",
              "strength": "100MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET, EXTENDED RELEASE",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "CARBIDOPA AND LEVODOPA",
          "active_ingredients": [
            {
              "name": "CARBIDOPA",
              "strength": "50MG"
            },
            {
              "name": "LEVODOPA",
              "strength": "200MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET, EXTENDED RELEASE",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}