Orange Book product · Brand (NDA)
PHEBURANE
SODIUM PHENYLBUTYRATE
At a glance
Jun 17, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 17, 2022
4 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
SODIUM PHENYLBUTYRATE
Strength
84GM/BOT
Dosage form
PELLETS
Route
ORAL
TE code
Not listed
Application
NDA 216513
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.
- 2025OLPRUVABrand (NDA)
NDA 214860 · ACER
- 1996BUPHENYLBrand (NDA)
NDA 020572 · HORIZON THERAP US
- 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.
