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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

ProductApplicantApplicationTEApproved
POTASSIUM ACETATERLDHOSPIRANDA 018896APJul 20, 1984

Generic (ANDA) products (3)

ProductApplicantApplicationTEApproved
POTASSIUM ACETATEFRESENIUS KABI USAANDA 217515APNov 27, 2024
POTASSIUM ACETATEEXELA PHARMAANDA 212692APOct 20, 2021
POTASSIUM ACETATEEXELA PHARMAANDA 206203Dec 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.

Agent CTA Background

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