SUFLAVE

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAzurity Pharmaceuticals, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
2433855001
1 KIT in 1 KIT (24338-550-01)

Annotations

Orange Book

N215344

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "d5710a04-2b0a-402c-a8b0-025766f1a437": {
      "match": "brand_token",
      "title": "SUFLAVE (POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, AND SODIUM CHLORIDE FOR ORAL SOLUTION) KIT [AZURITY PHARMACEUTICALS, INC.]",
      "spl_version": "1",
      "published_date": "2026-04-02"
    }
  },
  "productid": "24338-550_d5710a04-2b0a-402c-a8b0-025766f1a437",
  "productndc": "24338-550",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "215344",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT",
        "product_no": "001",
        "approval_date": "Jun 15, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "SUFLAVE",
  "active_ingred_unit": null,
  "application_number": "NDA215344",
  "marketing_category": "NDA",
  "nonproprietary_name": "polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution",
  "start_marketing_date": "20260401",
  "active_numerator_strength": null
}

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