Orange Book product · Brand (NDA)
SODIUM PHENYLACETATE AND SODIUM BENZOATE
SODIUM BENZOATE; SODIUM PHENYLACETATE
At a glance
Jun 10, 2021
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 10, 2021
5 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
SODIUM BENZOATE; SODIUM PHENYLACETATE
Strength
10%;10% (2GM/20ML;2GM/20ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
NDA 215025
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.
- 2005AMMONULBrand (NDA)
NDA 020645 · BAUSCH
- 1987UCEPHANBrand (NDA)
NDA 019530 · B BRAUN
- 2023SODIUM PHENYLACETATE AND SODIUM BENZOATEGeneric (ANDA)
ANDA 217526 · NAVINTA LLC
- 2017SODIUM PHENYLACETATE AND SODIUM BENZOATEGeneric (ANDA)
ANDA 208521 · MAIA PHARMS INC
- 2016SODIUM PHENYLACETATE AND SODIUM BENZOATEGeneric (ANDA)
ANDA 205880 · NAVINTA LLC
- 2016SODIUM PHENYLACETATE AND SODIUM BENZOATEGeneric (ANDA)
ANDA 207096 · AILEX PHARMS 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.
