{
  "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": "17",
          "submission_status": "AP",
          "submission_status_date": "20211110",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "69294",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/203479Orig1s017ltr.pdf",
              "date": "20211112",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20140929",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20210218",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "66306",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/203479Orig1s015ltr.pdf",
              "date": "20210222",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "20230426",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "74094",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203479s021lbl.pdf",
              "date": "20230427",
              "type": "Label"
            },
            {
              "id": "74103",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/203479Orig1s021ltr.pdf",
              "date": "20230427",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20131205",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "10219",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203479Orig1s001ltr.pdf",
              "date": "20131209",
              "type": "Letter"
            },
            {
              "id": "19474",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203479Orig1s001Lbl.pdf",
              "date": "20140113",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20190116",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "57302",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203479Orig1s011ltr.pdf",
              "date": "20190122",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "26",
          "submission_status": "AP",
          "submission_status_date": "20250613",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "82581",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/203479Orig1s026ltr.pdf",
              "date": "20250616",
              "type": "Letter"
            },
            {
              "id": "82583",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/203479s026lbl.pdf",
              "date": "20250616",
              "type": "Label"
            },
            {
              "id": "82584",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/203479s026lbl.pdf#page=38",
              "date": "20250616",
              "type": "Medication Guide"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20150915",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "40302",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203479s007s008lbl.pdf",
              "date": "20150916",
              "type": "Label"
            },
            {
              "id": "32432",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203479Orig1s007,s008ltr.pdf",
              "date": "20150917",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20160218",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20210729",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "68256",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/203479Orig1s016ltr.pdf",
              "date": "20210802",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "22",
          "submission_status": "AP",
          "submission_status_date": "20250122",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "80937",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/203479s022lbl.pdf",
              "date": "20250205",
              "type": "Label"
            },
            {
              "id": "81084",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/203479Orig1s022ltr.pdf",
              "date": "20250206",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20140325",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20200414",
          "review_priority": "901 REQUIRED",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "62570",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203479s014lbl.pdf",
              "date": "20200415",
              "type": "Label"
            },
            {
              "id": "62572",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203479Orig1s014ltr.pdf",
              "date": "20200415",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20130822",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "10220",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203479Orig1s002ltr.pdf",
              "date": "20130823",
              "type": "Letter"
            },
            {
              "id": "19475",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203479s002lbl.pdf",
              "date": "20130827",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20200729",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "64138",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203479Orig1s012ltr.pdf",
              "date": "20200730",
              "type": "Letter"
            },
            {
              "id": "64149",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203479s012lbl.pdf",
              "date": "20200730",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20170223",
          "review_priority": "901 REQUIRED",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "47352",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203479s010lbl.pdf",
              "date": "20170227",
              "type": "Label"
            },
            {
              "id": "47394",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203479Orig1s010ltr.pdf",
              "date": "20170302",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20150930",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "40303",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021590s028,203479s009lbl.pdf",
              "date": "20151210",
              "type": "Label"
            },
            {
              "id": "10222",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021590Orig1s028,203479Orig1s009ltr.pdf",
              "date": "20151002",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20130206",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "40301",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203479s000lbl.pdf",
              "date": "20130208",
              "type": "Label"
            },
            {
              "id": "43436",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203479_versacloz_toc.html",
              "date": "20130920",
              "type": "Review"
            },
            {
              "id": "44885",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203479Orig1s000SumR.pdf",
              "date": "20130920",
              "type": "Summary Review"
            },
            {
              "id": "24115",
              "title": "REMS",
              "url": "http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=351",
              "date": "20130208",
              "type": "Other"
            },
            {
              "id": "32431",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203479Orig1s000ltr.pdf",
              "date": "20130208",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20150915",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "10221",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203479Orig1s007,s008ltr.pdf",
              "date": "20150917",
              "type": "Letter"
            },
            {
              "id": "19476",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203479s007s008lbl.pdf",
              "date": "20150916",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA203479",
      "sponsor_name": "DOUGLAS PHARMS",
      "openfda": {
        "application_number": [
          "NDA203479"
        ],
        "brand_name": [
          "VERSACLOZ"
        ],
        "generic_name": [
          "CLOZAPINE"
        ],
        "manufacturer_name": [
          "TruPharma LLC"
        ],
        "product_ndc": [
          "52817-601"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CLOZAPINE"
        ],
        "rxcui": [
          "1369825",
          "1369831"
        ],
        "spl_id": [
          "38837e2a-084f-4179-e063-6394a90afd45"
        ],
        "spl_set_id": [
          "2592c9a8-fd74-4e0d-a895-b07b014cf355"
        ],
        "package_ndc": [
          "52817-601-38"
        ],
        "nui": [
          "N0000175430"
        ],
        "pharm_class_epc": [
          "Atypical Antipsychotic [EPC]"
        ],
        "unii": [
          "J60AR2IKIC"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "VERSACLOZ",
          "active_ingredients": [
            {
              "name": "CLOZAPINE",
              "strength": "50MG/ML"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SUSPENSION",
          "route": "ORAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}