Orange Book product · Brand (NDA)
FLUOROPLEX
FLUOROURACIL
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
FLUOROURACIL
Strength
1%
Dosage form
SOLUTION
Route
TOPICAL
TE code
Not listed
Application
NDA 016765
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 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
- 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.
