Orange Book product · Generic (ANDA)
FLUOROURACIL
FLUOROURACIL
At a glance
Mar 04, 1986
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 04, 1986
40 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
FLUOROURACIL
Strength
50MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
ANDA 088929
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of FLUOROURACIL
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- 2000CARACBrand (NDA)
NDA 020985 · EXTROVIS
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NDA 016831 · EXTROVIS
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NDA 016988 · CHARTWELL RX
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NDA 017959 · PHARMACIA AND UPJOHN
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NDA 016765 · ELORAC
- 2025FLUOROURACILGeneric (ANDA)
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ANDA 215699 · KINDOS
- 2024FLUOROURACILGeneric (ANDA)
ANDA 216494 · KINDOS
- 2023FLUOROURACILGeneric (ANDA)
ANDA 215612 · ENCUBE
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.

