{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-10-09", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "submissions": [ { "submission_type": "SUPPL", "submission_number": "14", "submission_status": "AP", "submission_status_date": "19951215", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "20", "submission_status": "AP", "submission_status_date": "19970613", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)", "application_docs": [ { "id": "20271", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019640_s020_HUMATROPE 5.pdf", "date": "20200323", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "12", "submission_status": "AP", "submission_status_date": "19950922", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "8", "submission_status": "AP", "submission_status_date": "19931118", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "10", "submission_status": "AP", "submission_status_date": "19950111", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "105", "submission_status": "AP", "submission_status_date": "20191028", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "60703", "title": "This Former NDA Was Deemed To Be a BLA on March 23, 2020.", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=faq.page#nda_bla", "date": "20200323", "type": "Other" }, { "id": "60708", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019640s091s105lbl.pdf", "date": "20200323", "type": "Label" }, { "id": "66424", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019640Orig1s091, s105ltr.pdf", "date": "20210301", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "6", "submission_status": "AP", "submission_status_date": "19920318", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "111", "submission_status": "AP", "submission_status_date": "20250709", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "82769", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/019640Orig1s111ltr.pdf", "date": "20250711", "type": "Letter" }, { "id": "82810", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019640s111lbl.pdf", "date": "20250711", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "47", "submission_status": "AP", "submission_status_date": "20061026", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "1432", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019640s047,019640s052ltr.pdf", "date": "20200323", "type": "Letter" }, { "id": "33820", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019640s047,019640s052lbl.pdf", "date": "20200323", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "103", "submission_status": "AP", "submission_status_date": "20161220", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "4", "submission_status": "AP", "submission_status_date": "19900423", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "45", "submission_status": "AP", "submission_status_date": "20051012", "review_priority": "UNKNOWN", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "11576", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019640s045lbl.pdf", "date": "20200323", "type": "Label" }, { "id": "1431", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019640s045ltr.pdf", "date": "20200323", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "98", "submission_status": "AP", "submission_status_date": "20141110", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "2", "submission_status": "AP", "submission_status_date": "19890510", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy" }, { "submission_type": "SUPPL", "submission_number": "29", "submission_status": "AP", "submission_status_date": "20010501", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "96", "submission_status": "AP", "submission_status_date": "20140811", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "19", "submission_status": "AP", "submission_status_date": "19970311", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "20270", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019640ap.pdf", "date": "20200323", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "33", "submission_status": "AP", "submission_status_date": "20030725", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "17498", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19640se1-033ltr.pdf", "date": "20200323", "type": "Letter" }, { "id": "20272", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19640se1-033_humatropen_lbl.pdf", "date": "20200323", "type": "Label" }, { "id": "33819", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019640_S033_HUMATROPE_AP.pdf", "date": "20200323", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "86", "submission_status": "AP", "submission_status_date": "20110822", "review_priority": "UNKNOWN", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "11581", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019640s086lbl.pdf", "date": "20200323", "type": "Label" }, { "id": "1438", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019640s086ltr.pdf", "date": "20200323", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "25", "submission_status": "AP", "submission_status_date": "20020610", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "1428", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19640s025ltr.pdf", "date": "20200323", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "78", "submission_status": "AP", "submission_status_date": "20100728", "review_priority": "UNKNOWN", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "11579", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019640s078_2lbl.pdf", "date": "20200323", "type": "Label" }, { "id": "1437", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019640s078ltr.pdf", "date": "20200323", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "92", "submission_status": "AP", "submission_status_date": "20140730", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "1439", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019640Orig1s092ltr.pdf", "date": "20200323", "type": "Letter" }, { "id": "33822", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019640s092lbl.pdf", "date": "20200323", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "17", "submission_status": "AP", "submission_status_date": "19960805", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "31", "submission_status": "AP", "submission_status_date": "20021204", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "17497", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19640slr031ltr.pdf", "date": "20200323", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "84", "submission_status": "AP", "submission_status_date": "20110223", "review_priority": "UNKNOWN", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "11580", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019640s084ltr.pdf", "date": "20200323", "type": "Letter" }, { "id": "17500", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019640s084lbl.pdf", "date": "20200323", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "90", "submission_status": "AP", "submission_status_date": "20130524", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "15", "submission_status": "AP", "submission_status_date": "19961107", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "68", "submission_status": "AP", "submission_status_date": "20090312", "review_priority": "UNKNOWN", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "11578", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019640s068lbl.pdf", "date": "20200323", "type": "Label" }, { "id": "1435", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019640s068ltr.pdf", "date": "20200323", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "21", "submission_status": "AP", "submission_status_date": "19971003", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "13", "submission_status": "AP", "submission_status_date": "19960801", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy" }, { "submission_type": "SUPPL", "submission_number": "108", "submission_status": "AP", "submission_status_date": "20231208", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "76755", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019640Orig1s108ltr.pdf", "date": "20231211", "type": "Letter" }, { "id": "76763", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019640s108lbl.pdf", "date": "20231211", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "58", "submission_status": "AP", "submission_status_date": "20061101", "review_priority": "UNKNOWN", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "1434", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019640s058ltr.pdf", "date": "20200323", "type": "Letter" }, { "id": "33821", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019640s058lbl.pdf", "date": "20200323", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "9", "submission_status": "AP", "submission_status_date": "19940415", "review_priority": "PRIORITY", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy" }, { "submission_type": "SUPPL", "submission_number": "11", "submission_status": "AP", "submission_status_date": "19950913", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "7", "submission_status": "AP", "submission_status_date": "19931214", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "70", "submission_status": "AP", "submission_status_date": "20090112", "review_priority": "N/A", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)", "application_docs": [ { "id": "1436", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019640s070ltr.pdf", "date": "20200323", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "104", "submission_status": "AP", "submission_status_date": "20161213", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "46149", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019640Orig1s104ltr.pdf", "date": "20200323", "type": "Letter" }, { "id": "46183", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019640s104lbl.pdf", "date": "20200323", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "5", "submission_status": "AP", "submission_status_date": "19901011", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "110", "submission_status": "AP", "submission_status_date": "20251125", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "84324", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/019640Orig1s110ltr.pdf", "date": "20251128", "type": "Letter" }, { "id": "84338", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019640s110lbl.pdf", "date": "20251128", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "46", "submission_status": "AP", "submission_status_date": "20060628", "review_priority": "N/A", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)", "application_docs": [ { "id": "17499", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019640s046ltr.pdf", "date": "20200323", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "3", "submission_status": "AP", "submission_status_date": "19890404", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "52", "submission_status": "AP", "submission_status_date": "20061026", "review_priority": "N/A", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)", "application_docs": [ { "id": "11577", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019640s047,019640s052lbl.pdf", "date": "20200323", "type": "Label" }, { "id": "1433", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019640s047,019640s052ltr.pdf", "date": "20200323", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "97", "submission_status": "AP", "submission_status_date": "20140912", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "1", "submission_status": "AP", "submission_status_date": "19870623", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "ORIG", "submission_number": "1", "submission_status": "AP", "submission_status_date": "19861016", "review_priority": "PRIORITY", "submission_class_code": "TYPE 5", "submission_class_code_description": "Type 5 - New Formulation or New Manufacturer", "submission_property_type": [ { "code": "Orphan" } ] }, { "submission_type": "SUPPL", "submission_number": "28", "submission_status": "AP", "submission_status_date": "20010117", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "95", "submission_status": "AP", "submission_status_date": "20140411", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "26", "submission_status": "AP", "submission_status_date": "20010212", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "40", "submission_status": "AP", "submission_status_date": "20040922", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "11575", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19640s040lbl.pdf", "date": "20200323", "type": "Label" }, { "id": "1430", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19640s040rev2.pdf", "date": "20200323", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "93", "submission_status": "AP", "submission_status_date": "20140124", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "18", "submission_status": "AP", "submission_status_date": "19970311", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "40942", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019640ap.pdf", "date": "20200323", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "32", "submission_status": "AP", "submission_status_date": "20030324", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "40944", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019640_S032_HUMATROPE_AP.pdf", "date": "20200323", "type": "Review" }, { "id": "1429", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19640slr032ltr.pdf", "date": "20200323", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "24", "submission_status": "AP", "submission_status_date": "19990907", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "91", "submission_status": "AP", "submission_status_date": "20191028", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "60702", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019640Orig1s091, s105ltr.pdf", "date": "20200323", "type": "Letter" }, { "id": "60709", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019640s091s105lbl.pdf", "date": "20200323", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "16", "submission_status": "AP", "submission_status_date": "19961122", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "30", "submission_status": "AP", "submission_status_date": "20010522", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "22", "submission_status": "AP", "submission_status_date": "19990204", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)", "application_docs": [ { "id": "40943", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019640_s022_HUMATROPE.pdf", "date": "20200323", "type": "Review" } ] } ], "application_number": "BLA019640", "sponsor_name": "LILLY", "openfda": { "application_number": [ "BLA019640" ], "brand_name": [ "HUMATROPE" ], "generic_name": [ "SOMATROPIN" ], "manufacturer_name": [ "Eli Lilly and Company" ], "product_ndc": [ "0002-8147", "0002-8148", "0002-8149" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAMUSCULAR", "SUBCUTANEOUS" ], "rxcui": [ "582969", "582971", "582974", "582976", "729232", "729234" ], "spl_id": [ "32f865e2-68df-47bc-b392-21b696a9f845" ], "spl_set_id": [ "a774e1ae-3997-49ee-8b0e-99a2b315d409" ], "package_ndc": [ "0002-8147-01", "0002-7554-01", "0002-7618-01", "0002-8148-01", "0002-7555-01", "0002-7619-01", "0002-8149-01", "0002-7556-01" ] }, "products": [ { "product_number": "001", "reference_drug": "No", "brand_name": "HUMATROPE", "active_ingredients": [ { "name": "SOMATROPIN", "strength": "2MG/VIAL" } ], "reference_standard": "No", "dosage_form": "INJECTABLE", "route": "INJECTION", "marketing_status": "Discontinued" }, { "product_number": "006", "reference_drug": "No", "brand_name": "HUMATROPE", "active_ingredients": [ { "name": "SOMATROPIN", "strength": "12MG/VIAL" } ], "reference_standard": "No", "dosage_form": "INJECTABLE", "route": "INJECTION", "marketing_status": "Prescription" }, { "product_number": "004", "reference_drug": "No", "brand_name": "HUMATROPE", "active_ingredients": [ { "name": "SOMATROPIN", "strength": "5MG/VIAL" } ], "reference_standard": "No", "dosage_form": "INJECTABLE", "route": "INJECTION", "marketing_status": "Prescription" }, { "product_number": "007", "reference_drug": "No", "brand_name": "HUMATROPE", "active_ingredients": [ { "name": "SOMATROPIN", "strength": "24MG/VIAL" } ], "reference_standard": "No", "dosage_form": "INJECTABLE", "route": "INJECTION", "marketing_status": "Prescription" }, { "product_number": "005", "reference_drug": "No", "brand_name": "HUMATROPE", "active_ingredients": [ { "name": "SOMATROPIN", "strength": "6MG/VIAL" } ], "reference_standard": "No", "dosage_form": "INJECTABLE", "route": "INJECTION", "marketing_status": "Prescription" } ] } ] }