{
  "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": "2026-10-23",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 41
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20250331",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20150302",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20180928",
          "submission_class_code": "N/A",
          "submission_class_code_description": "Not Applicable"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20121119",
          "submission_class_code": "N/A",
          "submission_class_code_description": "Not Applicable",
          "application_docs": [
            {
              "id": "55945",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202261Orig1s000Ltr_TALtr.pdf",
              "date": "20181015",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20190821",
          "submission_class_code": "N/A",
          "submission_class_code_description": "Not Applicable"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20160613",
          "submission_class_code": "N/A",
          "submission_class_code_description": "Not Applicable"
        }
      ],
      "application_number": "ANDA202261",
      "sponsor_name": "AUROBINDO PHARMA LTD",
      "openfda": {
        "application_number": [
          "ANDA202261"
        ],
        "brand_name": [
          "MINOCYCLINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "MINOCYCLINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Aurobindo Pharma Limited"
        ],
        "product_ndc": [
          "65862-554",
          "65862-883",
          "65862-555",
          "65862-884",
          "65862-556",
          "65862-885",
          "65862-557",
          "65862-558"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "MINOCYCLINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "629695",
          "629697",
          "629699",
          "858062",
          "858372",
          "1013659",
          "1013662",
          "1013665"
        ],
        "spl_id": [
          "5569f0f6-b36f-4149-aee7-2699fa5ebe53"
        ],
        "spl_set_id": [
          "e7b88a48-12b3-461d-b356-0d7ae4e8fd44"
        ],
        "package_ndc": [
          "65862-554-30",
          "65862-554-01",
          "65862-554-99",
          "65862-883-30",
          "65862-883-01",
          "65862-883-05",
          "65862-883-99",
          "65862-555-30",
          "65862-555-99",
          "65862-884-30",
          "65862-884-01",
          "65862-884-05",
          "65862-884-99",
          "65862-556-30",
          "65862-556-01",
          "65862-556-99",
          "65862-885-30",
          "65862-885-01",
          "65862-885-05",
          "65862-885-99",
          "65862-557-30",
          "65862-557-99",
          "65862-558-30",
          "65862-558-01",
          "65862-558-99"
        ],
        "unii": [
          "0020414E5U"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "MINOCYCLINE HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "MINOCYCLINE HYDROCHLORIDE",
              "strength": "EQ 45MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET, EXTENDED RELEASE",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "008",
          "reference_drug": "No",
          "brand_name": "MINOCYCLINE HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "MINOCYCLINE HYDROCHLORIDE",
              "strength": "EQ 55MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET, EXTENDED RELEASE",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "006",
          "reference_drug": "No",
          "brand_name": "MINOCYCLINE HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "MINOCYCLINE HYDROCHLORIDE",
              "strength": "EQ 80MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET, EXTENDED RELEASE",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "004",
          "reference_drug": "No",
          "brand_name": "MINOCYCLINE HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "MINOCYCLINE HYDROCHLORIDE",
              "strength": "EQ 115MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET, EXTENDED RELEASE",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "MINOCYCLINE HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "MINOCYCLINE HYDROCHLORIDE",
              "strength": "EQ 65MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET, EXTENDED RELEASE",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "007",
          "reference_drug": "No",
          "brand_name": "MINOCYCLINE HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "MINOCYCLINE HYDROCHLORIDE",
              "strength": "EQ 105MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET, EXTENDED RELEASE",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "005",
          "reference_drug": "No",
          "brand_name": "MINOCYCLINE HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "MINOCYCLINE HYDROCHLORIDE",
              "strength": "EQ 135MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET, EXTENDED RELEASE",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "003",
          "reference_drug": "No",
          "brand_name": "MINOCYCLINE HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "MINOCYCLINE HYDROCHLORIDE",
              "strength": "EQ 90MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET, EXTENDED RELEASE",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}