OXALIPLATIN

{
  "unii": {
    "unii": "04ZR38536J",
    "rxcui": "32592",
    "inchikey": "ZROHGHOFXNOHSO-BNTLRKBRSA-L",
    "display_name": "OXALIPLATIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "1ac38523-480b-4c0f-97a1-7dfa1432923c": {
      "match": "brand_token",
      "title": "OXALIPLATIN INJECTION, SOLUTION [SHANDONG NEW TIME PHARMACEUTICAL CO., LTD.]",
      "spl_version": "2",
      "published_date": "2026-04-15"
    }
  },
  "productid": "0955-1731_0bef8406-8dab-0ad0-e063-6394a90a60d0",
  "productndc": "0955-1731",
  "dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
  "orange_book": {
    "appl_no": "021759",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Jan 31, 2005"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "100MG/20ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Jan 31, 2005"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "200MG/40ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "003",
        "approval_date": "Nov 17, 2006"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OXALIPLATIN",
  "shortage_reason": "Oxaliplatin Injection",
  "shortage_status": "current",
  "proprietary_name": "OXALIPLATIN",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA021759",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "oxaliplatin",
  "start_marketing_date": "20150901",
  "active_numerator_strength": "5"
}