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United States · US · US:71274-170_ad61f987-e1eb-4da6-9060-cb1915d3636f

Joenja

Orange BookUNIISPLATC L03AX22

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerPharming Healthcare Inc.
CountryUS (United States)
ATC codeL03AX22
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7127417060
    1 BOTTLE, PLASTIC in 1 CARTON (71274-170-60) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
3700M1H39Q
LENIOLISIB PHOSPHATE
Orange Book
N217759
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "3700M1H39Q",
    "rxcui": null,
    "inchikey": "XXEDEGOAYSGNPS-ZOWNYOTGSA-N",
    "display_name": "LENIOLISIB PHOSPHATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "eefbcef8-2130-4654-8f29-b58077e08212": {
      "match": "brand_token",
      "title": "JOENJA (LENIOLISIB) TABLET, FILM COATED [PHARMING HEALTHCARE INC.]",
      "spl_version": "6",
      "published_date": "2025-06-12"
    }
  },
  "productid": "71274-170_ad61f987-e1eb-4da6-9060-cb1915d3636f",
  "productndc": "71274-170",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "217759",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 70MG BASE",
        "product_no": "001",
        "approval_date": "Mar 24, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LENIOLISIB PHOSPHATE",
  "proprietary_name": "Joenja",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA217759",
  "marketing_category": "NDA",
  "nonproprietary_name": "Leniolisib",
  "start_marketing_date": "20230329",
  "active_numerator_strength": "70"
}

Related drugs

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