MYDAYIS

{
  "route": "ORAL",
  "spl_meta": {
    "141a7970-3f06-44ea-9ab7-aeece2c085fc": {
      "match": "brand_token",
      "title": "MYDAYIS (DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, AND AMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.]",
      "spl_version": "13",
      "published_date": "2026-05-06"
    }
  },
  "productid": "54092-474_13a2ab7d-af84-4e46-a58f-9e9c17b5c0e5",
  "productndc": "54092-474",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "022063",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB2",
        "strength": "3.125MG;3.125MG;3.125MG;3.125MG",
        "product_no": "001",
        "approval_date": "Jun 20, 2017"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB2",
        "strength": "6.25MG;6.25MG;6.25MG;6.25MG",
        "product_no": "002",
        "approval_date": "Jun 20, 2017"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB2",
        "strength": "9.375MG;9.375MG;9.375MG;9.375MG",
        "product_no": "003",
        "approval_date": "Jun 20, 2017"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB2",
        "strength": "12.5MG;12.5MG;12.5MG;12.5MG",
        "product_no": "004",
        "approval_date": "Jun 20, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE",
  "shortage_reason": "Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet",
  "shortage_status": "current",
  "proprietary_name": "MYDAYIS",
  "active_ingred_unit": "mg/1; mg/1; mg/1; mg/1",
  "application_number": "NDA022063",
  "marketing_category": "NDA",
  "nonproprietary_name": "DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE",
  "start_marketing_date": "20170620",
  "active_numerator_strength": "9.375; 9.375; 9.375; 9.375"
}