Orange Book product · Generic (ANDA)
FLUCYTOSINE
FLUCYTOSINE
At a glance
Jul 23, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 23, 2025
11 mo ago
Today
Pharmaceutical detail
Active ingredient
FLUCYTOSINE
Strength
250MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
ANDA 218005
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of FLUCYTOSINE
- —ANCOBONBrand (NDA)
NDA 017001 · BAUSCH
- 2020FLUCYTOSINEGeneric (ANDA)
ANDA 213665 · AUROBINDO PHARMA LTD
- 2020FLUCYTOSINEGeneric (ANDA)
ANDA 212632 · STRIDES PHARMA
- 2018FLUCYTOSINEGeneric (ANDA)
ANDA 207536 · STRIDES PHARMA
- 2017FLUCYTOSINEGeneric (ANDA)
ANDA 206550 · HIKMA
- 2017FLUCYTOSINEGeneric (ANDA)
ANDA 204652 · NOVEL LABS INC
- 2011FLUCYTOSINEGeneric (ANDA)
ANDA 201566 · SIGMAPHARM LABS LLC
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.
