Dulera

{
  "unii": {
    "unii": "W34SHF8J2K",
    "rxcui": "998038",
    "inchikey": "RATSWNOMCHFQGJ-TUYNVFRMSA-N;RATSWNOMCHFQGJ-AYJOUMQSSA-N",
    "display_name": "FORMOTEROL FUMARATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "RESPIRATORY (INHALATION)",
  "spl_meta": {
    "8f399784-f257-4f31-b3dc-368bf2a1864d": {
      "match": "brand_token",
      "title": "DULERA (MOMETASONE FUROATE AND FORMOTEROL FUMARATE DIHYDRATE) AEROSOL [ORGANON LLC]",
      "spl_version": "7",
      "published_date": "2026-02-02"
    }
  },
  "productid": "78206-125_74079d8a-85a1-4736-8486-76624af02194",
  "productndc": "78206-125",
  "dosage_form": "AEROSOL",
  "orange_book": {
    "appl_no": "022518",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.005MG/INH;0.1MG/INH",
        "product_no": "001",
        "approval_date": "Jun 22, 2010"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.005MG/INH;0.2MG/INH",
        "product_no": "002",
        "approval_date": "Jun 22, 2010"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.005MG/INH;0.05MG/INH",
        "product_no": "003",
        "approval_date": "Aug 12, 2019"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FORMOTEROL FUMARATE; MOMETASONE FUROATE",
  "proprietary_name": "Dulera",
  "active_ingred_unit": "ug/1; ug/1",
  "application_number": "NDA022518",
  "marketing_category": "NDA",
  "nonproprietary_name": "mometasone furoate and formoterol fumarate dihydrate",
  "start_marketing_date": "20210601",
  "active_numerator_strength": "5; 50"
}