Orange Book product · Brand (NDA)
UCEPHAN
SODIUM BENZOATE; SODIUM PHENYLACETATE
At a glance
Dec 23, 1987
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 23, 1987
39 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
SODIUM BENZOATE; SODIUM PHENYLACETATE
Strength
100MG/ML;100MG/ML
Dosage form
SOLUTION
Route
ORAL
TE code
Not listed
Application
NDA 019530
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 2021SODIUM PHENYLACETATE AND SODIUM BENZOATEBrand (NDA)
NDA 215025 · MAIA PHARMS INC
- 2005AMMONULBrand (NDA)
NDA 020645 · BAUSCH
- 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.
