{
  "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": "2026-07-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19640603",
          "review_priority": "PRIORITY",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "39",
          "submission_status": "AP",
          "submission_status_date": "20040624",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "397",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/15197scm036,scf037,scp038,scm039ltr.pdf",
              "date": "20040625",
              "type": "Letter"
            },
            {
              "id": "33133",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/15197scm036,scf037,scp038,scm039_amicar_lbl.pdf",
              "date": "20040625",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "37",
          "submission_status": "AP",
          "submission_status_date": "20040624",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "396",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/15197scm036,scf037,scp038,scm039ltr.pdf",
              "date": "20040625",
              "type": "Letter"
            },
            {
              "id": "33132",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/15197scm036,scf037,scp038,scm039_amicar_lbl.pdf",
              "date": "20040625",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "29",
          "submission_status": "AP",
          "submission_status_date": "19920211",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "43",
          "submission_status": "AP",
          "submission_status_date": "20080819",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "10856",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015197s043,015230s035lbl.pdf",
              "date": "20080826",
              "type": "Label"
            },
            {
              "id": "12079",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/015230s035, 015197s043ltr.pdf",
              "date": "20080822",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "35",
          "submission_status": "AP",
          "submission_status_date": "20001127",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "27",
          "submission_status": "AP",
          "submission_status_date": "19860117",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "19810630",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "33",
          "submission_status": "AP",
          "submission_status_date": "20001002",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "25",
          "submission_status": "AP",
          "submission_status_date": "19821210",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "23",
          "submission_status": "AP",
          "submission_status_date": "19900403",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "19770209",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "38",
          "submission_status": "AP",
          "submission_status_date": "20040624",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "10855",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/15197scm036,scf037,scp038,scm039_amicar_lbl.pdf",
              "date": "20040625",
              "type": "Label"
            },
            {
              "id": "12077",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/15197scm036,scf037,scp038,scm039ltr.pdf",
              "date": "20040625",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "36",
          "submission_status": "AP",
          "submission_status_date": "20040624",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "33131",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/15197scm036,scf037,scp038,scm039_amicar_lbl.pdf",
              "date": "20040625",
              "type": "Label"
            },
            {
              "id": "395",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/15197scm036,scf037,scp038,scm039ltr.pdf",
              "date": "20040625",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "28",
          "submission_status": "AP",
          "submission_status_date": "19920813",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "34",
          "submission_status": "AP",
          "submission_status_date": "20000403",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "26",
          "submission_status": "AP",
          "submission_status_date": "19830606",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "40",
          "submission_status": "AP",
          "submission_status_date": "20040824",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "12078",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/15197s040,15229s031,15230s031ltr.pdf",
              "date": "20040825",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "32",
          "submission_status": "AP",
          "submission_status_date": "19991001",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "24",
          "submission_status": "AP",
          "submission_status_date": "19820922",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "30",
          "submission_status": "AP",
          "submission_status_date": "19970416",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "22",
          "submission_status": "AP",
          "submission_status_date": "19821022",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        }
      ],
      "application_number": "NDA015197",
      "sponsor_name": "HIKMA",
      "openfda": {
        "application_number": [
          "NDA015197"
        ],
        "brand_name": [
          "AMINOCAPROIC ACID"
        ],
        "generic_name": [
          "AMINOCAPROIC ACID"
        ],
        "manufacturer_name": [
          "Hikma Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "0054-1110",
          "0054-1100"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "AMINOCAPROIC ACID"
        ],
        "rxcui": [
          "476271",
          "582299"
        ],
        "spl_id": [
          "7b8f0ddb-00fd-4c22-afae-afe636f95f3a"
        ],
        "spl_set_id": [
          "7b8f0ddb-00fd-4c22-afae-afe636f95f3a"
        ],
        "package_ndc": [
          "0054-1110-13",
          "0054-1100-58"
        ],
        "nui": [
          "N0000175634",
          "N0000175632"
        ],
        "pharm_class_epc": [
          "Antifibrinolytic Agent [EPC]"
        ],
        "pharm_class_pe": [
          "Decreased Fibrinolysis [PE]"
        ],
        "unii": [
          "U6F3787206"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "AMICAR",
          "active_ingredients": [
            {
              "name": "AMINOCAPROIC ACID",
              "strength": "500MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "AMICAR",
          "active_ingredients": [
            {
              "name": "AMINOCAPROIC ACID",
              "strength": "1GM"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}