{
  "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": "5",
          "submission_status": "AP",
          "submission_status_date": "20200402",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20151019",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20200402",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20120207"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20151019",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20221028",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20221028",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "ANDA079165",
      "sponsor_name": "MLV",
      "openfda": {
        "application_number": [
          "ANDA079165"
        ],
        "brand_name": [
          "ROPINIROLE"
        ],
        "generic_name": [
          "ROPINIROLE"
        ],
        "manufacturer_name": [
          "Marlex Pharmaceuticals Inc"
        ],
        "product_ndc": [
          "10135-673",
          "10135-674",
          "10135-675",
          "10135-676",
          "10135-677",
          "10135-678",
          "10135-679"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ROPINIROLE HYDROCHLORIDE"
        ],
        "rxcui": [
          "283858",
          "312845",
          "312846",
          "312847",
          "312849",
          "314208",
          "562704"
        ],
        "spl_id": [
          "441e0572-3413-1a21-e063-6294a90a8e6a"
        ],
        "spl_set_id": [
          "35d90f6f-3116-4afa-be2d-b65c160e8ab3"
        ],
        "package_ndc": [
          "10135-673-01",
          "10135-674-01",
          "10135-675-01",
          "10135-676-01",
          "10135-677-01",
          "10135-678-01",
          "10135-679-01"
        ],
        "unii": [
          "D7ZD41RZI9"
        ]
      },
      "products": [
        {
          "product_number": "007",
          "reference_drug": "No",
          "brand_name": "ROPINIROLE HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "ROPINIROLE HYDROCHLORIDE",
              "strength": "EQ 5MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "005",
          "reference_drug": "No",
          "brand_name": "ROPINIROLE HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "ROPINIROLE HYDROCHLORIDE",
              "strength": "EQ 3MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "003",
          "reference_drug": "No",
          "brand_name": "ROPINIROLE HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "ROPINIROLE HYDROCHLORIDE",
              "strength": "EQ 1MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "ROPINIROLE HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "ROPINIROLE HYDROCHLORIDE",
              "strength": "EQ 0.25MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "006",
          "reference_drug": "No",
          "brand_name": "ROPINIROLE HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "ROPINIROLE HYDROCHLORIDE",
              "strength": "EQ 4MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "004",
          "reference_drug": "No",
          "brand_name": "ROPINIROLE HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "ROPINIROLE HYDROCHLORIDE",
              "strength": "EQ 2MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "ROPINIROLE HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "ROPINIROLE HYDROCHLORIDE",
              "strength": "EQ 0.5MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}