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United States · US · US:84552-500_334df051-2b2d-01fe-e063-6394a90a05f5
Gozellix
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTelix Innovations SA
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1184552500251 KIT in 1 CARTON (84552-500-25) * 2.5 mL in 1 VIAL, MULTI-DOSE (84552-502-25) * 6.4 mL in 1 VIAL, MULTI-DOSE (84552-503-64) * 2 mL in 1 AMPULE (84552-504-25) * 1 POWDER, FOR SOLUTION in 1 VIAL, MULTI-DOSE (84552-501-25)
- ndc1184552500641 KIT in 1 CARTON (84552-500-64) * 2.5 mL in 1 VIAL, MULTI-DOSE (84552-502-25) * 6.4 mL in 1 VIAL, MULTI-DOSE (84552-503-64) * 2 mL in 1 AMPULE (84552-504-25) * 1 POWDER, FOR SOLUTION in 1 VIAL, MULTI-DOSE (84552-501-25)
Annotations
Orange Book
N219592
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"abeab169-e38e-433a-b8a9-f1dab31518c8": {
"match": "brand_token",
"title": "GOZELLIX (GOZETOTIDE) KIT [TELIX INNOVATIONS SA]",
"spl_version": "2",
"published_date": "2025-04-23"
}
},
"productid": "84552-500_334df051-2b2d-01fe-e063-6394a90a05f5",
"productndc": "84552-500",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "219592",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "N/A",
"product_no": "001",
"approval_date": "Mar 20, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Gozellix",
"active_ingred_unit": null,
"application_number": "NDA219592",
"marketing_category": "NDA",
"nonproprietary_name": "GOZETOTIDE",
"start_marketing_date": "20250320",
"active_numerator_strength": null
}Access this data programmatically
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