{
  "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": "7",
          "submission_status": "AP",
          "submission_status_date": "20230210",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "73468",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210303Orig1s007ltr.pdf",
              "date": "20230213",
              "type": "Letter"
            },
            {
              "id": "73474",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210303s007lbl.pdf",
              "date": "20230213",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20200715",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "63969",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210303Orig1s005ltr.pdf",
              "date": "20200720",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20180625",
          "review_priority": "PRIORITY",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "54682",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210303Orig1s000Ltr.pdf",
              "date": "20180626",
              "type": "Letter"
            },
            {
              "id": "54683",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210303Orig1s000lbl.pdf",
              "date": "20180626",
              "type": "Label"
            },
            {
              "id": "55017",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210303Orig1s000TOC.html",
              "date": "20180727",
              "type": "Review"
            }
          ]
        }
      ],
      "application_number": "NDA210303",
      "sponsor_name": "CIPLA USA",
      "openfda": {
        "application_number": [
          "NDA210303"
        ],
        "brand_name": [
          "ZEMDRI (PLAZOMICIN)"
        ],
        "generic_name": [
          "PLAZOMICIN"
        ],
        "manufacturer_name": [
          "Cipla Therapeutics Inc.",
          "Cipla USA Inc.",
          "Achaogen, Inc."
        ],
        "product_ndc": [
          "80735-820",
          "69097-820",
          "71045-010"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "PLAZOMICIN"
        ],
        "rxcui": [
          "2049553",
          "2049558"
        ],
        "spl_id": [
          "2b813678-540b-41e8-bed5-609cc99fd663",
          "b2d9319a-6c34-4851-8486-3d956e916f53",
          "7803b863-697d-4d96-911f-5a229bbd8272"
        ],
        "spl_set_id": [
          "1243fcd3-de84-428b-901e-d83d65e4d98c",
          "eccf9fd9-53ac-4252-a106-5567b3a82a70",
          "0b82ffed-27f4-4f5c-8135-670c148f0e12"
        ],
        "package_ndc": [
          "80735-820-37",
          "80735-820-96",
          "69097-820-37",
          "69097-820-96",
          "71045-010-01",
          "71045-010-02"
        ],
        "unii": [
          "LYO9XZ250J"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "ZEMDRI",
          "active_ingredients": [
            {
              "name": "PLAZOMICIN SULFATE",
              "strength": "EQ 500MG BASE/10ML (EQ 50MG BASE/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SOLUTION",
          "route": "INTRAVENOUS",
          "marketing_status": "Discontinued"
        }
      ]
    }
  ]
}