Orange Book product · Generic (ANDA)
FLUOROURACIL
FLUOROURACIL
At a glance
Feb 12, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 12, 2025
1 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
FLUOROURACIL
Strength
5%
Dosage form
CREAM
Route
TOPICAL
TE code
AB
Application
ANDA 216942
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of FLUOROURACIL
- 2026FAVLYXABrand (NDA)
NDA 220201 · AVYXA HOLDINGS
- 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 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.
