Orange Book product · Brand (NDA)
AMMONUL
SODIUM BENZOATE; SODIUM PHENYLACETATE
At a glance
Feb 17, 2005
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 17, 2005
21 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
SODIUM BENZOATE; SODIUM PHENYLACETATE
Strength
10%;10% (5GM/50ML;5GM/50ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 020645
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.
- 2021SODIUM PHENYLACETATE AND SODIUM BENZOATEBrand (NDA)
NDA 215025 · MAIA PHARMS INC
- 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.
