{
  "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": "26",
          "submission_status": "AP",
          "submission_status_date": "20130301",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "6416",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021902Orig1s026ltr.pdf",
              "date": "20130304",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20071219",
          "review_priority": "UNKNOWN",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "6413",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021902s002ltr.pdf",
              "date": "20080109",
              "type": "Letter"
            },
            {
              "id": "16541",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021902s002lbl.pdf",
              "date": "20071227",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "30",
          "submission_status": "AP",
          "submission_status_date": "20160708",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20061031",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "42342",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021902s000TOC.html",
              "date": "20070108",
              "type": "Review"
            },
            {
              "id": "16539",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021902lbl.pdf",
              "date": "20061106",
              "type": "Label"
            },
            {
              "id": "28807",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021902s000ltr.pdf",
              "date": "20061106",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "29",
          "submission_status": "AP",
          "submission_status_date": "20150706",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20080213",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "27",
          "submission_status": "AP",
          "submission_status_date": "20130531",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "33",
          "submission_status": "AP",
          "submission_status_date": "20181219",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "56898",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021902s033lbl.pdf",
              "date": "20181220",
              "type": "Label"
            },
            {
              "id": "56947",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021902Orig1s033Ltr.pdf",
              "date": "20181221",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "25",
          "submission_status": "AP",
          "submission_status_date": "20121119",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "37845",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021902s025lbl.pdf",
              "date": "20121126",
              "type": "Label"
            },
            {
              "id": "6415",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021902Orig1s025ltr.pdf",
              "date": "20121121",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20070627",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20080918",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "6414",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021902s017ltr.pdf",
              "date": "20080923",
              "type": "Letter"
            },
            {
              "id": "16542",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021902s017lbl.pdf",
              "date": "20080919",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20070601",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "16540",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021902s001lbl.pdf",
              "date": "20070604",
              "type": "Label"
            },
            {
              "id": "28808",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021902s001ltr.pdf",
              "date": "20070607",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "28",
          "submission_status": "AP",
          "submission_status_date": "20130509",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        }
      ],
      "application_number": "NDA021902",
      "sponsor_name": "ANI PHARMS",
      "openfda": {
        "application_number": [
          "NDA021902"
        ],
        "brand_name": [
          "VEREGEN"
        ],
        "generic_name": [
          "SINECATECHINS"
        ],
        "manufacturer_name": [
          "ANI Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "62559-385"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "SINECATECHINS"
        ],
        "rxcui": [
          "753350",
          "795918"
        ],
        "spl_id": [
          "64ad4fa5-8381-41db-8d9b-62fa44843180"
        ],
        "spl_set_id": [
          "f0fc1e21-e3cf-4bce-860c-307f670b192e"
        ],
        "package_ndc": [
          "62559-385-30",
          "62559-385-02",
          "62559-385-26"
        ],
        "unii": [
          "T432289GYZ"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "VEREGEN",
          "active_ingredients": [
            {
              "name": "SINECATECHINS",
              "strength": "15%"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "OINTMENT",
          "route": "TOPICAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}