{
  "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": "9",
          "submission_status": "AP",
          "submission_status_date": "20241031",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20231215",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20191009",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20180918",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20000317",
          "application_docs": [
            {
              "id": "53968",
              "title": "Safety Labeling Change Order Letter",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/slc/2018/075523_SLCOrderLtr.pdf",
              "date": "20180501",
              "type": "Other"
            },
            {
              "id": "76097",
              "url": "https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17",
              "date": "20231102",
              "type": "REMS"
            },
            {
              "id": "22481",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75523_Pentazocine_Naloxone.pdf",
              "date": "20000317",
              "type": "Review"
            },
            {
              "id": "30923",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75523ltr.pdf",
              "date": "20000317",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20251223",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20251215",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20210304",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20180921",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20170331",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "ANDA075523",
      "sponsor_name": "SUN PHARM INDS LTD",
      "openfda": {
        "application_number": [
          "ANDA075523"
        ],
        "brand_name": [
          "PENTAZOCINE AND NALOXONE"
        ],
        "generic_name": [
          "PENTAZOCINE AND NALOXONE"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "63304-506"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "NALOXONE HYDROCHLORIDE",
          "PENTAZOCINE"
        ],
        "rxcui": [
          "312289"
        ],
        "spl_id": [
          "48ee2bd7-f7c9-4bf8-8932-ba9065c64cf3"
        ],
        "spl_set_id": [
          "41ebdaaf-3bbc-419f-b996-0341efc14623"
        ],
        "package_ndc": [
          "63304-506-01"
        ],
        "nui": [
          "N0000175686",
          "N0000175688",
          "N0000175685"
        ],
        "pharm_class_moa": [
          "Competitive Opioid Antagonists [MoA]",
          "Partial Opioid Agonists [MoA]"
        ],
        "pharm_class_epc": [
          "Partial Opioid Agonist/Antagonist [EPC]"
        ],
        "unii": [
          "F850569PQR",
          "RP4A60D26L"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "NALOXONE HYDROCHLORIDE",
              "strength": "EQ 0.5MG BASE"
            },
            {
              "name": "PENTAZOCINE HYDROCHLORIDE",
              "strength": "EQ 50MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}