{
  "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": "29",
          "submission_status": "AP",
          "submission_status_date": "20170329",
          "submission_public_notes": "Please see <a href=\"https://www.fda.gov/STIC/\">www.fda.gov/STIC</a> for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "47785",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050693s029,050730s037lbl.pdf",
              "date": "20170330",
              "type": "Label"
            },
            {
              "id": "47838",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050693Orig1s029,050730Orig1s037ltr.pdf",
              "date": "20170403",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20020722",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "8017",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50670slr019ltr.pdf",
              "date": "20020722",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "27",
          "submission_status": "AP",
          "submission_status_date": "20170210",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "47181",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050693Orig1s027,050730Orig1s035ltr.pdf",
              "date": "20170213",
              "type": "Letter"
            },
            {
              "id": "47182",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050693s27-050730s35lbl.pdf",
              "date": "20170210",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20021016",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "8016",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50670slr017,50693slr005,50730slr007ltr.pdf",
              "date": "20021016",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20121102",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "8020",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050693Orig1s019,050710Oirg1s034,050711Orig1s032,050730Orig1s027,050784Orig1s019ltr.pdf",
              "date": "20121106",
              "type": "Letter"
            },
            {
              "id": "39126",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s019,050710s034,050711s032,050730s029,050784s019lbl.pdf",
              "date": "20121106",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "25",
          "submission_status": "AP",
          "submission_status_date": "20141105",
          "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": "20001113",
          "review_priority": "UNKNOWN",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "39123",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-670S015_Zithromax_prntlbl.pdf",
              "date": "20001113",
              "type": "Label"
            },
            {
              "id": "42681",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-670S015_Zithromax.html",
              "date": "20001113",
              "type": "Review"
            },
            {
              "id": "8015",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-670S015_Zithromax_Approv.pdf",
              "date": "20001113",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20110128",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "18031",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050693s017,050730s026lbl.pdf",
              "date": "20110204",
              "type": "Label"
            },
            {
              "id": "30290",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050693s017,050710s033,050711s031,050730s026,050733s030,050784s018ltr.pdf",
              "date": "20110203",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "31",
          "submission_status": "AP",
          "submission_status_date": "20190424",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "58415",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050693s031,050730s041lbl.pdf",
              "date": "20190425",
              "type": "Label"
            },
            {
              "id": "58432",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050693Orig1s031,050730Orig1s041ltr.pdf",
              "date": "20190426",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19991122",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "23",
          "submission_status": "AP",
          "submission_status_date": "20130219",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "18033",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050693s023,050730s031lbl.pdf",
              "date": "20130221",
              "type": "Label"
            },
            {
              "id": "30292",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050693Orig1s023,050730Orig1s031ltr.pdf",
              "date": "20130221",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20100811",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "39125",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050693s015,050730s025lbl.pdf",
              "date": "20100819",
              "type": "Label"
            },
            {
              "id": "8019",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050693s015,050730s025ltr.pdf",
              "date": "20100817",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "20140606",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "39127",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050693s021,050730s029lbl.pdf",
              "date": "20140610",
              "type": "Label"
            },
            {
              "id": "30291",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050693Orig1s021,050730Orig1s029ltr.pdf",
              "date": "20140611",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20040324",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "18029",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50670slr021,50693slr008,50730slr011_zithromax_lbl.pdf",
              "date": "20040405",
              "type": "Label"
            },
            {
              "id": "30287",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50670slr021,50693slr008,50730slr011ltr.pdf",
              "date": "20040328",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "34",
          "submission_status": "AP",
          "submission_status_date": "20211122",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "69375",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050730s043,050693s034lbl.pdf",
              "date": "20211122",
              "type": "Label"
            },
            {
              "id": "69392",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050693Orig1s034;050730Orig1s043ltr.pdf",
              "date": "20211123",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "26",
          "submission_status": "AP",
          "submission_status_date": "20160523",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "39128",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050693s026,050730s034lbl.pdf",
              "date": "20160525",
              "type": "Label"
            },
            {
              "id": "30293",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050693Orig1s026,050730Orig1s034ltr.pdf",
              "date": "20160525",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20001111",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "22",
          "submission_status": "AP",
          "submission_status_date": "20120606",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "8021",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050693s022,050710s038,050711s035,050730s030,050733s034,050784s022ltr.pdf",
              "date": "20120608",
              "type": "Letter"
            },
            {
              "id": "18032",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050693s022,050710s038,050711s035,050730s030,050733s034,050784s022lbl.pdf",
              "date": "20120611",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20090306",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "18030",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050693s014,050730s021lbl.pdf",
              "date": "20090403",
              "type": "Label"
            },
            {
              "id": "30289",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050693s014,050730s021ltr.pdf",
              "date": "20090310",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20071025",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "30288",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050670s024, 050693s010, 050730s014ltr.pdf",
              "date": "20071108",
              "type": "Letter"
            },
            {
              "id": "39124",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050670s024,050693s010,050730s014lbl.pdf",
              "date": "20071107",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19940928",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "44203",
              "url": "http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm343281.htm",
              "date": "20130312",
              "type": "Other Important Information from FDA"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20040115",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "8018",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50670slr022,50693slr009,50730slr012ltr.pdf",
              "date": "20040122",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA050693",
      "sponsor_name": "PFIZER",
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "ZITHROMAX",
          "active_ingredients": [
            {
              "name": "AZITHROMYCIN",
              "strength": "EQ 1GM BASE/PACKET"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "FOR SUSPENSION",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        }
      ]
    }
  ]
}