FDA Orange Book · active-ingredient family
Sodium benzoate; sodium phenylacetate
Sodium benzoate; sodium phenylacetate is approved as 3 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SODIUM PHENYLACETATE AND SODIUM BENZOATE · NDA 215025
3
Brand (NDA)
4
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SODIUM PHENYLACETATE AND SODIUM BENZOATERLD | MAIA PHARMS INC | NDA 215025 | AP | Jun 10, 2021 | |
| AMMONULRLD | BAUSCH | NDA 020645 | — | Feb 17, 2005 | |
| UCEPHAN | B BRAUN | NDA 019530 | — | Dec 23, 1987 |
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SODIUM PHENYLACETATE AND SODIUM BENZOATE | NAVINTA LLC | ANDA 217526 | AP | Jul 14, 2023 | |
| SODIUM PHENYLACETATE AND SODIUM BENZOATE | MAIA PHARMS INC | ANDA 208521 | AP | May 08, 2017 | |
| SODIUM PHENYLACETATE AND SODIUM BENZOATE | NAVINTA LLC | ANDA 205880 | AP | Aug 04, 2016 | |
| SODIUM PHENYLACETATE AND SODIUM BENZOATE | AILEX PHARMS LLC | ANDA 207096 | AP | Feb 24, 2016 |
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.
Sodium benzoate; sodium phenylacetate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
