drugsfda_detail.json•2.48 kB
{
"meta": {
"results": {
"skip": 0,
"limit": 1,
"total": 1
}
},
"results": [
{
"application_number": "BLA125514",
"sponsor_name": "MERCK SHARP DOHME",
"openfda": {
"application_number": ["BLA125514"],
"brand_name": ["KEYTRUDA"],
"generic_name": ["PEMBROLIZUMAB"],
"manufacturer_name": ["Merck Sharp & Dohme Corp."],
"substance_name": ["PEMBROLIZUMAB"],
"product_ndc": ["0006-3026-02", "0006-3029-02"],
"spl_set_id": ["c0e2de11-29e0-48a1-92f0-d9cb4dd56b15"],
"unii": ["DPT0O3T46P"]
},
"products": [
{
"product_number": "001",
"reference_drug": "Yes",
"brand_name": "KEYTRUDA",
"active_ingredients": [
{
"name": "PEMBROLIZUMAB",
"strength": "100MG/4ML"
}
],
"reference_standard": "Yes",
"dosage_form": "INJECTION, SOLUTION",
"route": "INTRAVENOUS",
"marketing_status": "Prescription"
},
{
"product_number": "002",
"reference_drug": "Yes",
"brand_name": "KEYTRUDA",
"active_ingredients": [
{
"name": "PEMBROLIZUMAB",
"strength": "50MG/VIAL"
}
],
"reference_standard": "Yes",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"route": "INTRAVENOUS",
"marketing_status": "Prescription"
}
],
"submissions": [
{
"submission_type": "BLA",
"submission_number": "125514",
"submission_status": "AP",
"submission_status_date": "20140904",
"review_priority": "P",
"submission_class_code": "BLA",
"submission_class_code_description": "Biologic License Application",
"application_docs": [
{
"id": "52674",
"url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125514lbl.pdf",
"date": "20140905",
"type": "Label"
}
]
},
{
"submission_type": "SUPPL",
"submission_number": "109",
"submission_status": "AP",
"submission_status_date": "20230316",
"submission_class_code": "SUPPL",
"submission_class_code_description": "Supplement"
}
]
}
]
}