Details for New Drug Application (NDA): 214805

NDA 214805 describes SODIUM ACETATE, which is a drug marketed by Amneal, Extrovis, Fresenius Kabi Usa, Hikma, Hospira, Milla Pharms, and Somerset Theraps Llc, and is included in seven NDAs. It is available from six suppliers. Additional details are available on the SODIUM ACETATE profile page.

The generic ingredient in SODIUM ACETATE is sodium acetate. There is one drug master file entry for this compound. Six 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	MILLA PHARMACEUTICALS INC.	71357-002	71357-002-10	10 VIAL, SINGLE-DOSE in 1 CASE (71357-002-10) / 20 mL in 1 VIAL, SINGLE-DOSE (71357-002-01)
SODIUM ACETATE	sodium acetate	SOLUTION;INTRAVENOUS	214805	ANDA	MILLA PHARMACEUTICALS INC.	71357-007	71357-007-10	10 VIAL, PHARMACY BULK PACKAGE in 1 CASE (71357-007-10) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (71357-007-01)

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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