Orange Book product · Brand (NDA)
TOLAK
FLUOROURACIL
At a glance
Sep 18, 2015
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 18, 2015
10 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
FLUOROURACIL
Strength
4%
Dosage form
CREAM
Route
TOPICAL
TE code
Not listed
Application
NDA 022259
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.
- 2026FAVLYXABrand (NDA)
NDA 220201 · AVYXA HOLDINGS
- 2016FLUOROURACILBrand (NDA)
NDA 012209 · SPECTRUM PHARMS
- 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.
