Orange Book product · Brand (NDA)
BUPHENYL
SODIUM PHENYLBUTYRATE
At a glance
May 13, 1996
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 13, 1996
30 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
SODIUM PHENYLBUTYRATE
Strength
500MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 020572
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 2025OLPRUVABrand (NDA)
NDA 214860 · ACER
- 2022PHEBURANEBrand (NDA)
NDA 216513 · MEDUNIK
- 1996BUPHENYLBrand (NDA)
NDA 020573 · HORIZON THERAP US
- 2026SODIUM PHENYLBUTYRATEGeneric (ANDA)
ANDA 220418 · NAVINTA LLC
- 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.
