{
  "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": "2026-05-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "25",
          "submission_status": "AP",
          "submission_status_date": "20150320",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "27502",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021332Orig1s025ltr.pdf",
              "date": "20150413",
              "type": "Letter"
            },
            {
              "id": "36673",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021332s025lbl.pdf",
              "date": "20150324",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "23",
          "submission_status": "AP",
          "submission_status_date": "20150225",
          "review_priority": "901 REQUIRED",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "5062",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021332Orig1s023ltr.pdf",
              "date": "20150227",
              "type": "Letter"
            },
            {
              "id": "15206",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021332s023lbl.pdf",
              "date": "20150303",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20140627",
          "review_priority": "UNKNOWN",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "5060",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021332Orig1s007,s016ltr.pdf",
              "date": "20140630",
              "type": "Letter"
            },
            {
              "id": "15205",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021332s007_S016.pdf",
              "date": "20140701",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20050316",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "36670",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021332lbl.pdf",
              "date": "20050318",
              "type": "Label"
            },
            {
              "id": "42103",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21-332_Symlin.html",
              "date": "20050614",
              "type": "Review"
            },
            {
              "id": "5059",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021332ltr.pdf",
              "date": "20050318",
              "type": "Letter"
            },
            {
              "id": "23256",
              "url": "http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089141.pdf",
              "date": "20070228",
              "type": "Medication Guide"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "28",
          "submission_status": "AP",
          "submission_status_date": "20191218",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "61358",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021332s028lbl.pdf",
              "date": "20191219",
              "type": "Label"
            },
            {
              "id": "61383",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021332Orig1s028ltr.pdf",
              "date": "20191223",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "26",
          "submission_status": "AP",
          "submission_status_date": "20170308",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "47544",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021332Orig1s026ltr.pdf",
              "date": "20170314",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "24",
          "submission_status": "AP",
          "submission_status_date": "20150807",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "27501",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021332Orig1s024ltr.pdf",
              "date": "20150811",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20140627",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "27499",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021332Orig1s007,s016ltr.pdf",
              "date": "20140630",
              "type": "Letter"
            },
            {
              "id": "36672",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021332s007_S016.pdf",
              "date": "20140701",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "20",
          "submission_status": "AP",
          "submission_status_date": "20120103",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "27500",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021332s020ltr.pdf",
              "date": "20120105",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20080804",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "5061",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021332s010ltr.pdf",
              "date": "20080806",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20070925",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "27498",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021332s006ltr.pdf",
              "date": "20071004",
              "type": "Letter"
            },
            {
              "id": "36671",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021332s006lbl.pdf",
              "date": "20070926",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA021332",
      "sponsor_name": "ASTRAZENECA AB",
      "openfda": {
        "application_number": [
          "NDA021332"
        ],
        "brand_name": [
          "SYMLINPEN"
        ],
        "generic_name": [
          "PRAMLINTIDE ACETATE"
        ],
        "manufacturer_name": [
          "AstraZeneca Pharmaceuticals LP"
        ],
        "product_ndc": [
          "0310-6615",
          "0310-6627"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "PRAMLINTIDE ACETATE"
        ],
        "rxcui": [
          "861042",
          "861043",
          "861044",
          "861045"
        ],
        "spl_id": [
          "a84753f1-6ac5-4a47-a382-29972938ccaa"
        ],
        "spl_set_id": [
          "4aea30ff-eb0d-45c1-b114-3127966328ff"
        ],
        "package_ndc": [
          "0310-6615-02",
          "0310-6627-02"
        ],
        "unii": [
          "726I6TE06G"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "SYMLIN",
          "active_ingredients": [
            {
              "name": "PRAMLINTIDE ACETATE",
              "strength": "EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "SUBCUTANEOUS",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "SYMLIN",
          "active_ingredients": [
            {
              "name": "PRAMLINTIDE ACETATE",
              "strength": "EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "SUBCUTANEOUS",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "SYMLIN",
          "active_ingredients": [
            {
              "name": "PRAMLINTIDE ACETATE",
              "strength": "EQ 3MG BASE/5ML (EQ 600MCG BASE/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "SUBCUTANEOUS",
          "marketing_status": "Discontinued"
        }
      ]
    }
  ]
}