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POTASSIUM ACETATE

ANDA

POTASSIUM ACETATE | A212692 | EXELA PHARMA SCIENCES LLC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: POTASSIUM ACETATE(TE code: AP)

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from APP Pharmaceuticals LLC FDA-2009-P-0102 APP Pharmaceuticals LLC filed a citizen petition requesting that the FDA modify the Orange Book listing for potassium acetate in plastic container 2 mEq/mL, an injectable solution originally approved under NDA 018896 to Hospira on July 20, 1984. The specific regulatory action requested is not detail	Other	2009-02-26	Granted	APP Pharmaceuticals LLC

Source: Regulations.gov. FDA citizen petitions matched by application number.

API Supply Chain6 active DMFs

6 active API suppliers hold Drug Master Files for this ingredient.

VASA PHARMACHEM PVT LTDPOTASSIUM ACETATE BP/EP/USP

DMF 360322021

HARMAN FINOCHEM LTDPOTASSIUM ACETATE USP

DMF 370192022

GLOBAL CALCIUM PRIVATE LTDPOTASSIUM ACETATE USP

DMF 380752023

QUALITY CHEMICALS SLPOTASSIUM ACETATE

DMF 392712023

MUBY CHEM PRIVATE LTDPOTASSIUM ACETATE USP

DMF 411362025

MAITHRI DRUGS PRIVATE LTDPOTASSIUM ACETATE USP

DMF 425322025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 2MEQ/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Oct 20, 2021

No patent or exclusivity listings for this strength.