{
  "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": "2026-10-30",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 37
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20250630",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN"
        }
      ],
      "application_number": "ANDA217998",
      "sponsor_name": "TARO",
      "openfda": {
        "application_number": [
          "ANDA217998"
        ],
        "brand_name": [
          "MINOXIDIL TOPICAL SOLUTION, 5%",
          "KEEPS MINOXIDIL TOPICAL SOLUTION, 5%"
        ],
        "generic_name": [
          "MINOXIDIL SOLUTION"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc.",
          "Keeps (30 Madison)"
        ],
        "product_ndc": [
          "51672-2151",
          "71713-102"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "MINOXIDIL"
        ],
        "rxcui": [
          "311724"
        ],
        "spl_id": [
          "4c37963d-9845-23d1-e063-6394a90aba45",
          "3bce6383-1106-5096-e063-6294a90ae8ff"
        ],
        "spl_set_id": [
          "acc5ad74-4558-4be9-aab4-94ad9ddad6b2",
          "236d9984-d9a3-a87d-e063-6394a90a4958"
        ],
        "package_ndc": [
          "51672-2151-4",
          "51672-2151-9",
          "71713-102-04",
          "71713-102-09"
        ],
        "nui": [
          "N0000175379",
          "N0000175564"
        ],
        "pharm_class_pe": [
          "Arteriolar Vasodilation [PE]"
        ],
        "pharm_class_epc": [
          "Arteriolar Vasodilator [EPC]"
        ],
        "unii": [
          "5965120SH1"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "MINOXIDIL EXTRA STRENGTH (FOR MEN)",
          "active_ingredients": [
            {
              "name": "MINOXIDIL",
              "strength": "5%"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SOLUTION",
          "route": "TOPICAL",
          "marketing_status": "Over-the-counter"
        }
      ]
    }
  ]
}