Details for New Drug Application (NDA): 214805

NDA 214805 describes SODIUM ACETATE, which is a drug marketed by Fresenius Kabi Usa, Hikma, Hospira, and Milla Pharms, and is included in four NDAs. It is available from five suppliers. Additional details are available on the SODIUM ACETATE profile page.

The generic ingredient in SODIUM ACETATE is sodium acetate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the sodium acetate profile page.

Summary for 214805

Tradename:	SODIUM ACETATE
Applicant:	Milla Pharms
Ingredient:	sodium acetate
Patents:	0

Suppliers and Packaging for NDA: 214805

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SODIUM ACETATE	sodium acetate	SOLUTION;INTRAVENOUS	214805	ANDA	WOODWARD PHARMA SERVICES LLC	69784-229	69784-229-10	10 VIAL, SINGLE-DOSE in 1 CASE (69784-229-10) / 20 mL in 1 VIAL, SINGLE-DOSE
SODIUM ACETATE	sodium acetate	SOLUTION;INTRAVENOUS	214805	ANDA	Woodward Pharma Services LLC	69784-230	69784-230-10	50 mL in 1 VIAL, PHARMACY BULK PACKAGE (69784-230-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	100MEQ/50ML (2MEQ/ML)
Approval Date:	May 4, 2021	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	400MEQ/100ML (4MEQ/ML)
Approval Date:	Aug 25, 2023	TE:	AP	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	200MEQ/100ML (2MEQ/ML)
Approval Date:	May 4, 2021	TE:	AP	RLD:	No

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