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United States · US · US:83831-120_8a1dd776-1219-455e-a47f-bc6fc921c15c
Frindovyx
Orange BookUNIISPLATC L01AA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAvyxa Pharma, LLC
CountryUS (United States)
ATC codeL01AA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1183831120021 VIAL, MULTI-DOSE in 1 CARTON (83831-120-02) / 2 mL in 1 VIAL, MULTI-DOSE
Annotations
UNII (FDA Substance ID)
8N3DW7272P
CYCLOPHOSPHAMIDE
RxCUI 3002
Orange Book
N210852
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "8N3DW7272P",
"rxcui": "3002",
"inchikey": "PWOQRKCAHTVFLB-UHFFFAOYSA-N",
"display_name": "CYCLOPHOSPHAMIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"5ad8ea65-4c98-487a-9c8d-df778765ec5e": {
"match": "brand_token",
"title": "FRINDOVYX (CYCLOPHOSPHAMIDE) INJECTION [AVYXA PHARMA, LLC]",
"spl_version": "10",
"published_date": "2025-08-14"
}
},
"productid": "83831-120_8a1dd776-1219-455e-a47f-bc6fc921c15c",
"productndc": "83831-120",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "210852",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "500MG/ML (500MG/ML)",
"product_no": "001",
"approval_date": "Jun 7, 2023"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "1GM/2ML (500MG/ML)",
"product_no": "002",
"approval_date": "Jun 7, 2023"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "2GM/4ML (500MG/ML)",
"product_no": "003",
"approval_date": "Jun 7, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CYCLOPHOSPHAMIDE",
"proprietary_name": "Frindovyx",
"active_ingred_unit": "g/2mL",
"application_number": "NDA210852",
"marketing_category": "NDA",
"nonproprietary_name": "Cyclophosphamide",
"start_marketing_date": "20250319",
"active_numerator_strength": "1"
}Related drugs
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- BECyclofosfamide Accord 1000 mgAccord Healthcare
- NLCyclofosfamide Accord 1000 mg, poeder voor oplossing voor injectie / infusieAccord Healthcare B.V.
- BECyclofosfamide Accord 200 mg/mlAccord Healthcare
- BECyclofosfamide Accord 200 mg/mlAccord Healthcare
- BECyclofosfamide Accord 200 mg/mlAccord Healthcare
- BECyclofosfamide Accord 200 mg/mlAccord Healthcare
- NLCyclofosfamide Accord 2000 mg, poeder voor oplossing voor injectie / infusieAccord Healthcare B.V.
- BECyclofosfamide Accord 500 mgAccord Healthcare
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