Plenamine

{
  "unii": {
    "unii": "OF5P57N2ZX",
    "rxcui": "426",
    "inchikey": "QNAYBMKLOCPYGJ-REOHCLBHSA-N",
    "display_name": "ALANINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "a3244d1a-45b0-4e4c-bd96-f0632d761a1f": {
      "match": "brand_token",
      "title": "PLENAMINE (LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, AND TYROSINE) SOLUTION [B. BRAUN MEDICAL INC.]",
      "spl_version": "9",
      "published_date": "2026-05-13"
    }
  },
  "productid": "0264-4500_905f7c55-bf0d-4150-90ef-e8f1a5455bc1",
  "productndc": "0264-4500",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "091112",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "15%(150GM/1000ML)",
        "product_no": "001",
        "approval_date": "Apr 13, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "15%(300GM/2000ML)",
        "product_no": "002",
        "approval_date": "Apr 13, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE",
  "proprietary_name": "Plenamine",
  "active_ingred_unit": "g/100mL; g/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
  "application_number": "ANDA091112",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE",
  "start_marketing_date": "20180928",
  "active_numerator_strength": "2.17; 1.47; 434; 749; 1.04; 894; 749; 1.04; 1.18; 749; 1.04; 894; 592; 749; 250; 39; 960"
}