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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 220274
Company: EXTROVIS

Products on ANDA 220274

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM ACETATE	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No
SODIUM ACETATE	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 220274

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/17/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 220274

SODIUM ACETATE

SOLUTION;INTRAVENOUS; 100MEQ/50ML (2MEQ/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SODIUM ACETATE	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	218469	AMNEAL
SODIUM ACETATE	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	220274	EXTROVIS
SODIUM ACETATE	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216920	HIKMA
SODIUM ACETATE	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	018893	HOSPIRA
SODIUM ACETATE	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	214805	MILLA PHARMS
SODIUM ACETATE	SODIUM ACETATE	100MEQ/50ML (2MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	219826	SOMERSET THERAPS LLC

SOLUTION;INTRAVENOUS; 200MEQ/100ML (2MEQ/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SODIUM ACETATE	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	218469	AMNEAL
SODIUM ACETATE	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	220274	EXTROVIS
SODIUM ACETATE	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216920	HIKMA
SODIUM ACETATE	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	018893	HOSPIRA
SODIUM ACETATE	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	214805	MILLA PHARMS
SODIUM ACETATE	SODIUM ACETATE	200MEQ/100ML (2MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	219826	SOMERSET THERAPS LLC

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