{
  "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": "22",
          "submission_status": "AP",
          "submission_status_date": "20160518",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20131024",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "15585",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021487s010s012s014,021627s008lbl.pdf",
              "date": "20131025",
              "type": "Label"
            },
            {
              "id": "27916",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021487Orig1s010,s012,s014,021627Orig1s008ltr.pdf",
              "date": "20131025",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20031016",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "42191",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-487_Namenda.html",
              "date": "20031231",
              "type": "Review"
            },
            {
              "id": "15583",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021487lbl.pdf",
              "date": "20031020",
              "type": "Label"
            },
            {
              "id": "27912",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21487ltr.pdf",
              "date": "20031022",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "20",
          "submission_status": "AP",
          "submission_status_date": "20150429",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20131024",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "5522",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021487Orig1s010,s012,s014,021627Orig1s008ltr.pdf",
              "date": "20131025",
              "type": "Letter"
            },
            {
              "id": "15584",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021487s010s012s014,021627s008lbl.pdf",
              "date": "20131025",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20131024",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "37054",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021487s010s012s014,021627s008lbl.pdf",
              "date": "20131025",
              "type": "Label"
            },
            {
              "id": "5521",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021487s010ltr.pdf021487Orig1s010,s012,s014,021627Orig1s008ltr.pdf",
              "date": "20131025",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20061004",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "5520",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021487s008,021627s001LTR.pdf",
              "date": "20061013",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20050517",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "5519",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021487s006ltr.pdf",
              "date": "20050520",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20050502",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "27914",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021487s004ltr.pdf",
              "date": "20050503",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20040922",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "27913",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21487s002ltr.pdf",
              "date": "20040929",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "25",
          "submission_status": "AP",
          "submission_status_date": "20181102",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "56283",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021487s025lbl.pdf",
              "date": "20181106",
              "type": "Label"
            },
            {
              "id": "56434",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021487Orig1s025ltr.pdf",
              "date": "20181114",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20130311",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "20160307",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20060419",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "27915",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021487s007, 021627s002LTR.pdf",
              "date": "20060421",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "20131114",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        }
      ],
      "application_number": "NDA021487",
      "sponsor_name": "ABBVIE",
      "openfda": {
        "application_number": [
          "NDA021487"
        ],
        "brand_name": [
          "MEMANTINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "MEMANTINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Actavis Pharma, Inc."
        ],
        "product_ndc": [
          "0591-3870",
          "0591-3875",
          "0591-3900"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "MEMANTINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "996561",
          "996571",
          "996572"
        ],
        "spl_id": [
          "985e1190-b8a0-4775-9a20-ad1924b14fb2"
        ],
        "spl_set_id": [
          "72973b46-f307-4a9e-8fb1-ad2cbccfd736"
        ],
        "package_ndc": [
          "0591-3870-60",
          "0591-3870-45",
          "0591-3870-44",
          "0591-3875-60",
          "0591-3875-45",
          "0591-3875-44",
          "0591-3900-87"
        ],
        "unii": [
          "JY0WD0UA60"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "NAMENDA",
          "active_ingredients": [
            {
              "name": "MEMANTINE HYDROCHLORIDE",
              "strength": "10MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Discontinued",
          "te_code": "AB"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "NAMENDA",
          "active_ingredients": [
            {
              "name": "MEMANTINE HYDROCHLORIDE",
              "strength": "5MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Discontinued",
          "te_code": "AB"
        }
      ]
    }
  ]
}