{
  "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": "2026-08-21",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "58",
          "submission_status": "AP",
          "submission_status_date": "19971113",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "72",
          "submission_status": "AP",
          "submission_status_date": "20130614",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "62",
          "submission_status": "AP",
          "submission_status_date": "19990421",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "85",
          "submission_status": "AP",
          "submission_status_date": "20251114",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "84178",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/012616s085lbl.pdf",
              "date": "20251117",
              "type": "Label"
            },
            {
              "id": "84180",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/012616Orig1s085ltr.pdf",
              "date": "20251118",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "19780104",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "69",
          "submission_status": "AP",
          "submission_status_date": "20110922",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "12023",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012616s069ltr.pdf",
              "date": "20110926",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "83",
          "submission_status": "AP",
          "submission_status_date": "20221219",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "72970",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/012616s083lbl.pdf",
              "date": "20221221",
              "type": "Label"
            },
            {
              "id": "72972",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/012616Orig1s083ltr.pdf",
              "date": "20221221",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "75",
          "submission_status": "AP",
          "submission_status_date": "20140306",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "12026",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/012616Orig1s075ltr.pdf",
              "date": "20140307",
              "type": "Letter"
            },
            {
              "id": "33089",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012616s075lbl.pdf",
              "date": "20140307",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "81",
          "submission_status": "AP",
          "submission_status_date": "20210219",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "66316",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/012616s081lbl.pdf",
              "date": "20210222",
              "type": "Label"
            },
            {
              "id": "66323",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/012616Orig1s081ltr.pdf",
              "date": "20210223",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "73",
          "submission_status": "AP",
          "submission_status_date": "20130612",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "10817",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012616s073lbl.pdf",
              "date": "20130618",
              "type": "Label"
            },
            {
              "id": "12024",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012616Orig1s073ltr.pdf",
              "date": "20130613",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "63",
          "submission_status": "AP",
          "submission_status_date": "20021126",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "55",
          "submission_status": "AP",
          "submission_status_date": "19900123",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "61",
          "submission_status": "AP",
          "submission_status_date": "19990113",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "37",
          "submission_status": "AP",
          "submission_status_date": "19971113",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19610127",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 4",
          "submission_class_code_description": "Type 4 - New Combination"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "78",
          "submission_status": "AP",
          "submission_status_date": "20190117",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "57247",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/012616s078lbl.pdf",
              "date": "20190118",
              "type": "Label"
            },
            {
              "id": "57249",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/012616Orig1s078ltr.pdf",
              "date": "20190118",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "76",
          "submission_status": "AP",
          "submission_status_date": "20141022",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "10818",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012616s076lbl.pdf",
              "date": "20141024",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "68",
          "submission_status": "AP",
          "submission_status_date": "20110519",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "10816",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/012616s068lbl.pdf",
              "date": "20110523",
              "type": "Label"
            },
            {
              "id": "12022",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/012616s068ltr.pdf",
              "date": "20110524",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "74",
          "submission_status": "AP",
          "submission_status_date": "20140117",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "12025",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/012616Orig1s074ltr.pdf",
              "date": "20140121",
              "type": "Letter"
            },
            {
              "id": "33088",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012616s074lbl.pdf",
              "date": "20140122",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "80",
          "submission_status": "AP",
          "submission_status_date": "20200820",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "64388",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/012616Orig1s080ltr.pdf",
              "date": "20200824",
              "type": "Letter"
            },
            {
              "id": "64435",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/012616s080lbl.pdf",
              "date": "20200827",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA012616",
      "sponsor_name": "PFIZER",
      "openfda": {
        "application_number": [
          "NDA012616"
        ],
        "brand_name": [
          "SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE"
        ],
        "generic_name": [
          "SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE"
        ],
        "manufacturer_name": [
          "Prasco Laboratories"
        ],
        "product_ndc": [
          "66993-188"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SPIRONOLACTONE",
          "HYDROCHLOROTHIAZIDE"
        ],
        "rxcui": [
          "198224"
        ],
        "spl_id": [
          "eca75090-9808-4673-bd7e-1ecd571d3b3e"
        ],
        "spl_set_id": [
          "9d350fa2-d568-4970-a7a5-d128ff5d0a2f"
        ],
        "package_ndc": [
          "66993-188-02"
        ],
        "nui": [
          "N0000175557",
          "N0000011310",
          "N0000175359",
          "N0000175419",
          "M0471776"
        ],
        "pharm_class_epc": [
          "Aldosterone Antagonist [EPC]",
          "Thiazide Diuretic [EPC]"
        ],
        "pharm_class_moa": [
          "Aldosterone Antagonists [MoA]"
        ],
        "pharm_class_pe": [
          "Increased Diuresis [PE]"
        ],
        "pharm_class_cs": [
          "Thiazides [CS]"
        ],
        "unii": [
          "27O7W4T232",
          "0J48LPH2TH"
        ]
      },
      "products": [
        {
          "product_number": "005",
          "reference_drug": "Yes",
          "brand_name": "ALDACTAZIDE",
          "active_ingredients": [
            {
              "name": "HYDROCHLOROTHIAZIDE",
              "strength": "50MG"
            },
            {
              "name": "SPIRONOLACTONE",
              "strength": "50MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "004",
          "reference_drug": "Yes",
          "brand_name": "ALDACTAZIDE",
          "active_ingredients": [
            {
              "name": "HYDROCHLOROTHIAZIDE",
              "strength": "25MG"
            },
            {
              "name": "SPIRONOLACTONE",
              "strength": "25MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}