TRILYTE

{
  "unii": {
    "unii": "G2M7P15E5P",
    "rxcui": "221147",
    "inchikey": null,
    "display_name": "POLYETHYLENE GLYCOL 3350",
    "substance_type": "polymer",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "79f5e596-8d51-4227-afcc-f5e341150957": {
      "match": "brand_token",
      "title": "TRILYTE (POLYETHYLENE GLYOCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [AUROBINDO PHARMA LIMITED]",
      "spl_version": "1",
      "published_date": "2026-04-20"
    }
  },
  "productid": "84386-013_79f5e596-8d51-4227-afcc-f5e341150957",
  "productndc": "84386-013",
  "dosage_form": "POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "076491",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT",
        "product_no": "001",
        "approval_date": "Feb 5, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE",
  "proprietary_name": "TRILYTE",
  "active_ingred_unit": "g/4L; g/4L; g/4L; g/4L",
  "application_number": "ANDA076491",
  "marketing_category": "ANDA",
  "nonproprietary_name": "polyethylene glyocol 3350, sodium chloride, sodium bicarbonate and potassium chloride",
  "start_marketing_date": "20260414",
  "active_numerator_strength": "420; 1.48; 5.72; 11.2"
}