Orange Book product · Brand (NDA)
FAVLYXA
FLUOROURACIL
At a glance
Feb 20, 2026
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 20, 2026
4 mo ago
Today
Pharmaceutical detail
Active ingredient
FLUOROURACIL
Strength
250MG/10ML (25MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 220201
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2016FLUOROURACILBrand (NDA)
NDA 012209 · SPECTRUM PHARMS
- 2015TOLAKBrand (NDA)
NDA 022259 · HILL DERMACEUTICALS
- 2000CARACBrand (NDA)
NDA 020985 · EXTROVIS
- —EFUDEXBrand (NDA)
NDA 016831 · EXTROVIS
- —FLUOROPLEXBrand (NDA)
NDA 016988 · CHARTWELL RX
- —ADRUCILBrand (NDA)
NDA 017959 · PHARMACIA AND UPJOHN
- —FLUOROPLEXBrand (NDA)
NDA 016765 · ELORAC
- 2025FLUOROURACILGeneric (ANDA)
ANDA 216942 · ENCUBE
- 2025FLUOROURACILGeneric (ANDA)
ANDA 215699 · KINDOS
- 2024FLUOROURACILGeneric (ANDA)
ANDA 216494 · KINDOS
- 2023FLUOROURACILGeneric (ANDA)
ANDA 215612 · ENCUBE
- 2023FLUOROURACILGeneric (ANDA)
ANDA 217676 · ALEMBIC
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
