{
  "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": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20091007"
        }
      ],
      "application_number": "ANDA090812",
      "sponsor_name": "ALLIED",
      "openfda": {
        "application_number": [
          "ANDA090812"
        ],
        "brand_name": [
          "POLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVE",
          "POLYETHYLENE GLYCOL 3350",
          "CLEARLAX",
          "EASYLAX"
        ],
        "generic_name": [
          "POLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVE",
          "POLYETHYLENE GLYCOL 3350"
        ],
        "manufacturer_name": [
          "LGM PHARMA SOLUTIONS, LLC",
          "Geri-Care Pharmaceutical Corp",
          "STRATEGIC SOURCING SERVICES LLC",
          "Pharmaceutica North America, Inc.",
          "VALU MERCHANDISERS COMPANY"
        ],
        "product_ndc": [
          "79739-7116",
          "57896-489",
          "70677-1068",
          "45861-083",
          "63941-489"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "POLYETHYLENE GLYCOL 3350"
        ],
        "rxcui": [
          "876193",
          "880407"
        ],
        "spl_id": [
          "fc3454ec-7729-4327-90f7-9e12dddb19d6",
          "ee3ad47b-8219-3bc4-e053-2a95a90af736",
          "374e2998-0c02-c804-e063-6394a90a67c4",
          "2f83c954-31c2-fa95-e063-6394a90a5861",
          "4615c684-e866-c269-e063-6294a90aa451"
        ],
        "spl_set_id": [
          "d78bead5-ff19-4d45-9003-ec131f1f5a13",
          "f4c7eb80-d8d5-406d-90d0-9d17914d71f2",
          "041157b8-476c-e7d2-e063-6394a90ac3a0",
          "d048111f-8144-4d51-a0c2-a967b2bce455",
          "6597811b-6471-5afd-e053-2991aa0a07c2"
        ],
        "package_ndc": [
          "79739-7116-1",
          "79739-7116-2",
          "79739-7116-3",
          "57896-489-14",
          "57896-489-30",
          "70677-1068-1",
          "70677-1068-2",
          "45861-083-05",
          "45861-083-06",
          "63941-489-14"
        ],
        "nui": [
          "N0000010288",
          "N0000175811",
          "N0000009871"
        ],
        "pharm_class_moa": [
          "Osmotic Activity [MoA]"
        ],
        "pharm_class_epc": [
          "Osmotic Laxative [EPC]"
        ],
        "pharm_class_pe": [
          "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"
        ],
        "unii": [
          "G2M7P15E5P"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "POLYETHYLENE GLYCOL 3350",
          "active_ingredients": [
            {
              "name": "POLYETHYLENE GLYCOL 3350",
              "strength": "17GM/SCOOPFUL"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "FOR SOLUTION",
          "route": "ORAL",
          "marketing_status": "Over-the-counter"
        }
      ]
    }
  ]
}