{
  "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": "4",
          "submission_status": "AP",
          "submission_status_date": "20201021",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20151211",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20201021",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20201021",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "ANDA206503",
      "sponsor_name": "SOMERSET THERAPS LLC",
      "openfda": {
        "application_number": [
          "ANDA206503"
        ],
        "brand_name": [
          "CYANOCOBALAMIN"
        ],
        "generic_name": [
          "CYANOCOBALAMIN"
        ],
        "manufacturer_name": [
          "Somerset Therapeutics, LLC"
        ],
        "product_ndc": [
          "70069-005",
          "70069-172"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "CYANOCOBALAMIN"
        ],
        "rxcui": [
          "309594"
        ],
        "spl_id": [
          "a10756d3-74a9-4adf-9d2a-0bbac8ad941b"
        ],
        "spl_set_id": [
          "41ac0dc1-0a71-4c69-8e25-ba838f5f16a3"
        ],
        "package_ndc": [
          "70069-005-01",
          "70069-005-10",
          "70069-172-01",
          "70069-172-10",
          "70069-172-25"
        ],
        "nui": [
          "M0022794",
          "N0000175951"
        ],
        "pharm_class_cs": [
          "Vitamin B 12 [CS]"
        ],
        "pharm_class_epc": [
          "Vitamin B12 [EPC]"
        ],
        "unii": [
          "P6YC3EG204"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "CYANOCOBALAMIN",
          "active_ingredients": [
            {
              "name": "CYANOCOBALAMIN",
              "strength": "1MG/ML"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        }
      ]
    }
  ]
}