{
  "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": "2026-06-09",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20010914",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20010814",
          "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": "20010216",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "18234",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50781lbl.pdf",
              "date": "20030502",
              "type": "Label"
            },
            {
              "id": "22236",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/50781_Arestin.html",
              "date": "20030307",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "20",
          "submission_status": "AP",
          "submission_status_date": "20170508",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "48327",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050781s020lbl.pdf",
              "date": "20170509",
              "type": "Label"
            },
            {
              "id": "48347",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050781Orig1s020ltr.pdf",
              "date": "20170510",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20080215",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "39323",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050781s012lbl.pdf",
              "date": "20080225",
              "type": "Label"
            },
            {
              "id": "8274",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050781s012ltr.pdf",
              "date": "20080220",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20011012",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20010814",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20010713",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20120727",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "39324",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050781s019lbl.pdf",
              "date": "20120731",
              "type": "Label"
            },
            {
              "id": "8275",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050781Orig1s019ltr.pdf",
              "date": "20120731",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "25",
          "submission_status": "AP",
          "submission_status_date": "20240524",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "78559",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050781s025lbl.pdf",
              "date": "20240528",
              "type": "Label"
            },
            {
              "id": "78563",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/050781Orig1s025ltr.pdf",
              "date": "20240528",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20080215",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20020128",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        }
      ],
      "application_number": "NDA050781",
      "sponsor_name": "ORAPHARMA",
      "openfda": {
        "application_number": [
          "NDA050781"
        ],
        "brand_name": [
          "ARESTIN"
        ],
        "generic_name": [
          "MINOCYCLINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "OraPharma, Inc."
        ],
        "product_ndc": [
          "65976-100"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "MINOCYCLINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "351121",
          "351974"
        ],
        "spl_id": [
          "668385ee-9443-4d20-b0ea-655c2526ca96"
        ],
        "spl_set_id": [
          "8515df41-1936-4f3b-86ba-d2bb2a8441fb"
        ],
        "package_ndc": [
          "65976-100-01",
          "65976-100-12",
          "65976-100-24"
        ],
        "unii": [
          "0020414E5U"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "ARESTIN",
          "active_ingredients": [
            {
              "name": "MINOCYCLINE HYDROCHLORIDE",
              "strength": "EQ 1MG BASE"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "POWDER, EXTENDED RELEASE",
          "route": "DENTAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}