Orange Book product · Generic (ANDA)
SODIUM PHENYLBUTYRATE
SODIUM PHENYLBUTYRATE
At a glance
Feb 17, 2026
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 17, 2026
4 mo ago
Today
Pharmaceutical detail
Active ingredient
SODIUM PHENYLBUTYRATE
Strength
500MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 220418
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of SODIUM PHENYLBUTYRATE
- 2025OLPRUVABrand (NDA)
NDA 214860 · ACER
- 2022PHEBURANEBrand (NDA)
NDA 216513 · MEDUNIK
- 1996BUPHENYLBrand (NDA)
NDA 020572 · HORIZON THERAP US
- 1996BUPHENYLBrand (NDA)
NDA 020573 · HORIZON THERAP US
- 2022SODIUM PHENYLBUTYRATEGeneric (ANDA)
ANDA 216462 · GLENMARK PHARMS LTD
- 2016SODIUM PHENYLBUTYRATEGeneric (ANDA)
ANDA 203918 · PH HEALTH
- 2016SODIUM PHENYLBUTYRATEGeneric (ANDA)
ANDA 204395 · PH HEALTH
- 2013SODIUM PHENYLBUTYRATEGeneric (ANDA)
ANDA 202819 · SIGMAPHARM LABS LLC
- 2011SODIUM PHENYLBUTYRATEGeneric (ANDA)
ANDA 090910 · ALVOGEN
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.
