FDA Orange Book · active-ingredient family
Potassium acetate
Potassium acetate is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:POTASSIUM ACETATE · NDA 018896
1
Brand (NDA)
3
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| POTASSIUM ACETATERLD | HOSPIRA | NDA 018896 | AP | Jul 20, 1984 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| POTASSIUM ACETATE | FRESENIUS KABI USA | ANDA 217515 | AP | Nov 27, 2024 | |
| POTASSIUM ACETATE | EXELA PHARMA | ANDA 212692 | AP | Oct 20, 2021 | |
| POTASSIUM ACETATE | EXELA PHARMA | ANDA 206203 | — | Dec 29, 2015 |
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.
Potassium acetate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

