Mixed Salts of a Single Entity Amphetamine Product

{
  "route": "ORAL",
  "spl_meta": {
    "304ff4db-201a-60a4-e054-00144ff8d46c": {
      "match": "brand_token",
      "title": "MIXED BERRY SORE THROAT AND COUGH LOZENGE (DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [MEIJER DISTRIBUTION, INC.]",
      "spl_version": "8",
      "published_date": "2026-02-03"
    }
  },
  "productid": "0406-8953_d35f2f82-b0de-4f2a-a740-3d95c364cd7b",
  "productndc": "0406-8953",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "211547",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "1.25MG;1.25MG;1.25MG;1.25MG",
        "product_no": "001",
        "approval_date": "Apr 22, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "2.5MG;2.5MG;2.5MG;2.5MG",
        "product_no": "002",
        "approval_date": "Apr 22, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "3.75MG;3.75MG;3.75MG;3.75MG",
        "product_no": "003",
        "approval_date": "Apr 22, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "5MG;5MG;5MG;5MG",
        "product_no": "004",
        "approval_date": "Apr 22, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "6.25MG;6.25MG;6.25MG;6.25MG",
        "product_no": "005",
        "approval_date": "Apr 22, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "7.5MG;7.5MG;7.5MG;7.5MG",
        "product_no": "006",
        "approval_date": "Apr 22, 2019"
      }
    ],
    "appl_type": "A"
  },
  "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": "Mixed Salts of a Single Entity Amphetamine Product",
  "active_ingred_unit": "mg/1; mg/1; mg/1; mg/1",
  "application_number": "ANDA211547",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate",
  "start_marketing_date": "20190422",
  "active_numerator_strength": "3.75; 3.75; 3.75; 3.75"
}