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United States · US · US:11797-110_23b3f0a7-bf0e-4221-a534-145f6c4ea8b7
DUVYZAT
Orange BookUNIISPLATC M09AX14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerItalfarmaco SPA
CountryUS (United States)
ATC codeM09AX14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1111797110021 BOTTLE in 1 CARTON (11797-110-02) / 140 mL in 1 BOTTLE (11797-110-01)
Annotations
UNII (FDA Substance ID)
5P60F84FBH
GIVINOSTAT
Orange Book
N217865
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "5P60F84FBH",
"rxcui": null,
"inchikey": "YALNUENQHAQXEA-UHFFFAOYSA-N",
"display_name": "GIVINOSTAT",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"1a28a3db-7880-4ac2-a2f2-2b4e362aafb6": {
"match": "brand_token",
"title": "DUVYZAT (GIVINOSTAT) SUSPENSION [ITALFARMACO SPA]",
"spl_version": "2",
"published_date": "2026-01-26"
}
},
"productid": "11797-110_23b3f0a7-bf0e-4221-a534-145f6c4ea8b7",
"productndc": "11797-110",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "217865",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 8.86MG BASE/ML",
"product_no": "001",
"approval_date": "Mar 21, 2024"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GIVINOSTAT",
"proprietary_name": "DUVYZAT",
"active_ingred_unit": "mg/mL",
"application_number": "NDA217865",
"marketing_category": "NDA",
"nonproprietary_name": "givinostat",
"start_marketing_date": "20240321",
"active_numerator_strength": "8.86"
}Related drugs
Other records sharing ATC code M09AX14.
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