FDA Orange Book · active-ingredient family
Sodium acetate
Sodium acetate is approved as 1 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SODIUM ACETATE · NDA 018893
1
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SODIUM ACETATERLD×3 | HOSPIRA | NDA 018893 | AP | May 04, 1983 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SODIUM ACETATE×2 | EXTROVIS | ANDA 220274 | AP | Apr 17, 2026 | |
| SODIUM ACETATE×3 | AMNEAL | ANDA 218469 | AP | Mar 02, 2026 | |
| SODIUM ACETATE×2 | SOMERSET THERAPS LLC | ANDA 219826 | AP | Sep 18, 2025 | |
| SODIUM ACETATE×3 | HIKMA | ANDA 216920 | AP | Mar 15, 2024 | |
| SODIUM ACETATE×4 | MILLA PHARMS | ANDA 214805 | AP | Jan 22, 2024 | |
| SODIUM ACETATE | FRESENIUS KABI USA | ANDA 206687 | AP | Oct 30, 2017 |
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 acetate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
