{
  "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": "18",
          "submission_status": "AP",
          "submission_status_date": "20190419",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "58389",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050537Orig1s040,050600Orig1s017,050615Orig1s018ltr.pdf",
              "date": "20190424",
              "type": "Letter"
            },
            {
              "id": "58706",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050537s040,050600s017,050615s018lbl.pdf",
              "date": "20190515",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20171116",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "50441",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050537s039,050600s016,050615s016lbl.pdf",
              "date": "20171117",
              "type": "Label"
            },
            {
              "id": "50453",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050537Orig1s039,050600Orig1s016,050615Orig1s016ltr.pdf",
              "date": "20171117",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20160115",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "39042",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050537s037,050600s014,050615s014lbl.pdf",
              "date": "20160126",
              "type": "Label"
            },
            {
              "id": "7889",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050537s037,050600s014,050615s014ltr.pdf",
              "date": "20160120",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20030530",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "17931",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50537slr026,50600slr007,50615slr005_cleocin_lbl.pdf",
              "date": "20030608",
              "type": "Label"
            },
            {
              "id": "30172",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50537slr026,50600slr007,50615slr005ltr.pdf",
              "date": "20030608",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20140404",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "17932",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050537s035,050600s013,050615s012lbl.pdf",
              "date": "20140408",
              "type": "Label"
            },
            {
              "id": "30173",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050600Orig1s013,050537Orig1s035,050615Orig1s012ltr.pdf",
              "date": "20140407",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20020714",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "39041",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50537s13lbl.pdf",
              "date": "20020714",
              "type": "Label"
            },
            {
              "id": "7888",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50537slr013,50600slr002,50615slr003ltr.pdf",
              "date": "20020714",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20191216",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "61321",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050537s041,050600s018,050615s019lbl.pdf",
              "date": "20191217",
              "type": "Label"
            },
            {
              "id": "61336",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050600Orig1s018,050615Orig1s019,050537Orig1s041ltr.pdf",
              "date": "20191219",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19870107",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "20251112",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "84150",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/050537s042,050600s020,050615s021lbl.pdf",
              "date": "20251113",
              "type": "Label"
            },
            {
              "id": "84162",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/050537Orig1s042,050600Orig1s020,050615Orig1s021ltr.pdf",
              "date": "20251113",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20150112",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "19980127",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        }
      ],
      "application_number": "NDA050615",
      "sponsor_name": "PFIZER",
      "openfda": {
        "application_number": [
          "NDA050615"
        ],
        "brand_name": [
          "CLINDAMYCIN PHOSPHATE"
        ],
        "generic_name": [
          "CLINDAMYCIN PHOSPHATE"
        ],
        "manufacturer_name": [
          "Mylan Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "59762-3743",
          "59762-3728",
          "59762-3744"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "CLINDAMYCIN PHOSPHATE"
        ],
        "rxcui": [
          "197519",
          "309333",
          "2676585"
        ],
        "spl_id": [
          "d4cce371-d34f-42f1-8cd4-0f154115db84"
        ],
        "spl_set_id": [
          "f7480256-8b32-419a-8983-e2c413040dba"
        ],
        "package_ndc": [
          "59762-3728-1",
          "59762-3728-2",
          "59762-3728-3",
          "59762-3744-1",
          "59762-3743-1",
          "59762-3743-2"
        ],
        "unii": [
          "EH6D7113I8"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "CLEOCIN T",
          "active_ingredients": [
            {
              "name": "CLINDAMYCIN PHOSPHATE",
              "strength": "EQ 1% BASE"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "GEL",
          "route": "TOPICAL",
          "marketing_status": "Prescription",
          "te_code": "AB1"
        }
      ]
    }
  ]
}