SOVUNA

{
  "unii": {
    "unii": "8Q2869CNVH",
    "rxcui": "153972",
    "inchikey": "JCBIVZZPXRZKTI-UHFFFAOYSA-N",
    "display_name": "HYDROXYCHLOROQUINE SULFATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "dd441154-b196-4d4c-bc56-2e37f345ef8d": {
      "match": "brand_token",
      "title": "SOVUNA (HYDROXYCHLOROQUINE SULFATE) TABLET, FILM COATED [ANI PHARMACEUTICALS, INC.]",
      "spl_version": "4",
      "published_date": "2025-01-31"
    }
  },
  "productid": "70954-805_f8c163b7-15a0-424d-b53d-05fb400948bf",
  "productndc": "70954-805",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "214581",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Jan 14, 2022"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Jan 14, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROXYCHLOROQUINE SULFATE",
  "shortage_reason": "Hydroxychloroquine Sulfate Tablet",
  "shortage_status": "current",
  "proprietary_name": "SOVUNA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA214581",
  "marketing_category": "NDA",
  "nonproprietary_name": "Hydroxychloroquine Sulfate",
  "start_marketing_date": "20230915",
  "active_numerator_strength": "300"
}