Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206203
Company: EXELA PHARMA

Products on ANDA 206203

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
POTASSIUM ACETATE	POTASSIUM ACETATE	2MEQ/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206203

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/29/2015	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/25/2017	SUPPL-2	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 206203

POTASSIUM ACETATE

INJECTABLE;INJECTION; 2MEQ/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
POTASSIUM ACETATE	POTASSIUM ACETATE	2MEQ/ML	INJECTABLE;INJECTION	Prescription	No	AP	206203	EXELA PHARMA
POTASSIUM ACETATE	POTASSIUM ACETATE	2MEQ/ML	INJECTABLE;INJECTION	Prescription	No	AP	212692	EXELA PHARMA
POTASSIUM ACETATE	POTASSIUM ACETATE	2MEQ/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018896	HOSPIRA