Premasol - sulfite-free (Amino Acid)

{
  "unii": {
    "unii": "OF5P57N2ZX",
    "rxcui": "426",
    "inchikey": "QNAYBMKLOCPYGJ-REOHCLBHSA-N",
    "display_name": "ALANINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "9afdcc3e-0d06-47f4-86ca-40da48b2b02b": {
      "match": "brand_token",
      "title": "PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE COMPANY]",
      "spl_version": "12",
      "published_date": "2026-05-11"
    }
  },
  "productid": "0338-1130_c874a813-b145-4f7f-833e-97d6c4dd727c",
  "productndc": "0338-1130",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "075880",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "6% (6GM/100ML)",
        "product_no": "001",
        "approval_date": "Jun 19, 2003"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10% (10GM/100ML)",
        "product_no": "002",
        "approval_date": "Jun 19, 2003"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALANINE; ARGININE; ASPARTIC ACID; CYSTEINE HYDROCHLORIDE; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; TAURINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE",
  "proprietary_name": "Premasol - sulfite-free (Amino Acid)",
  "active_ingred_unit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; g/100mL",
  "application_number": "ANDA075880",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE",
  "start_marketing_date": "20030619",
  "active_numerator_strength": ".54; 1.2; .32; .016; .5; .36; .48; .82; 1.4; .82; .34; .48; .68; .38; 25; .42; .2; .24; .78"
}