Emtricitabine and tenofovir disoproxil fumarate

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    "rxcui": "276237",
    "inchikey": "XQSPYNMVSIKCOC-NTSWFWBYSA-N",
    "display_name": "EMTRICITABINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "4feb83a5-9142-0c67-e063-6394a90a710f": {
      "match": "brand_token",
      "title": "EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.]",
      "spl_version": "1",
      "published_date": "2026-04-22"
    }
  },
  "productid": "70771-1622_8fb1b15c-e324-4410-9a1b-2b3a2ffee3f6",
  "productndc": "70771-1622",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "212689",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG;300MG",
        "product_no": "001",
        "approval_date": "Feb 28, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG;150MG",
        "product_no": "002",
        "approval_date": "Jul 1, 2021"
      },
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        "te_code": "AB",
        "strength": "133MG;200MG",
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        "approval_date": "Jul 1, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "167MG;250MG",
        "product_no": "004",
        "approval_date": "Jul 1, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE",
  "proprietary_name": "Emtricitabine and tenofovir disoproxil fumarate",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA212689",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Emtricitabine and tenofovir disoproxil fumarate",
  "start_marketing_date": "20210701",
  "active_numerator_strength": "167; 250"
}