{
  "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": "2026-07-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "33",
          "submission_status": "AP",
          "submission_status_date": "20190123",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "57343",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020579s033lbl.pdf",
              "date": "20190125",
              "type": "Label"
            },
            {
              "id": "57514",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020579Orig1s033ltr.pdf",
              "date": "20190213",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "25",
          "submission_status": "AP",
          "submission_status_date": "20091029",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "12768",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020579s025lbl.pdf",
              "date": "20091030",
              "type": "Label"
            },
            {
              "id": "2777",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020579s025ltr.pdf",
              "date": "20091119",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "19981208",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20051018",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "31",
          "submission_status": "AP",
          "submission_status_date": "20160121",
          "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": "19970825",
          "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": "20080429",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "2776",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020579s023ltr.pdf",
              "date": "20080505",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "20070216",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "12767",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020579s021lbl.pdf",
              "date": "20070221",
              "type": "Label"
            },
            {
              "id": "25222",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020579s021ltr.pdf",
              "date": "20070223",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20010820",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20000630",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "28",
          "submission_status": "AP",
          "submission_status_date": "20140720",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "25225",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020579Orig1s028ltr.pdf",
              "date": "20140724",
              "type": "Letter"
            },
            {
              "id": "34878",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020579s028lbl.pdf",
              "date": "20140724",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "19990902",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "26",
          "submission_status": "AP",
          "submission_status_date": "20091222",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "12769",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020579s026lbl.pdf",
              "date": "20100104",
              "type": "Label"
            },
            {
              "id": "25224",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020579s026ltr.pdf",
              "date": "20091229",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "19990119",
          "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": "19980526",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "24",
          "submission_status": "AP",
          "submission_status_date": "20081202",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "25223",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020579s024ltr.pdf",
              "date": "20081204",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20051018",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "2774",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020579s016ltr.pdf",
              "date": "20051025",
              "type": "Letter"
            },
            {
              "id": "34877",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020579s016lbl.pdf",
              "date": "20051024",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "20",
          "submission_status": "AP",
          "submission_status_date": "20070111",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "12766",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020579s020lbl.pdf",
              "date": "20070116",
              "type": "Label"
            },
            {
              "id": "2775",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020579s020ltr.pdf",
              "date": "20070116",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20011217",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20010606",
          "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": "19970415",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "41443",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020579_s000.pdf",
              "date": "20100316",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20000726",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "29",
          "submission_status": "AP",
          "submission_status_date": "20141020",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "52352",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020579_tamsulosin_Original_WR.pdf",
              "date": "20090917",
              "type": "Pediatric Written Request"
            },
            {
              "id": "52353",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020579_tamsulosin_Amendment_1.pdf",
              "date": "20090917",
              "type": "Pediatric Amendment 1"
            },
            {
              "id": "52354",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020579_tamsulosin_Amendment_2.pdf",
              "date": "20090917",
              "type": "Pediatric Amendment 2"
            },
            {
              "id": "52355",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020579_tamsulosin_Amendment_3.pdf",
              "date": "20090917",
              "type": "Pediatric Amendment 3"
            },
            {
              "id": "52929",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020579_Tamsulosin_Statistical_BPCA.pdf",
              "date": "20090917",
              "type": "Pediatric Statistical Review"
            },
            {
              "id": "52930",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020579_Tamsulosin_Clinpharm_BPCA.pdf",
              "date": "20090917",
              "type": "Pediatric Clinical Pharmacology Review"
            },
            {
              "id": "52931",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020579_Tamsulosin_Clinical_BPCA.pdf",
              "date": "20090917",
              "type": "Pediatric Medical Review"
            },
            {
              "id": "2779",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020579Orig1s029ltr.pdf",
              "date": "20141022",
              "type": "Letter"
            },
            {
              "id": "34879",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020579s029lbl.pdf",
              "date": "20141021",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20010501",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "27",
          "submission_status": "AP",
          "submission_status_date": "20110725",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "12770",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020579s027lbl.pdf",
              "date": "20110727",
              "type": "Label"
            },
            {
              "id": "2778",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020579s027ltr.pdf",
              "date": "20110727",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "19990223",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        }
      ],
      "application_number": "NDA020579",
      "sponsor_name": "SANOFI",
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "FLOMAX",
          "active_ingredients": [
            {
              "name": "TAMSULOSIN HYDROCHLORIDE",
              "strength": "0.4MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE",
          "route": "ORAL",
          "marketing_status": "Discontinued",
          "te_code": "AB"
        }
      ]
    }
  ]
}