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Last Updated: October 28, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 214805


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NDA 214805 describes SODIUM ACETATE, which is a drug marketed by Fresenius Kabi Usa, Hospira, and Milla Pharms, and is included in three NDAs. It is available from three 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. Three 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
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 214805
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SODIUM ACETATE sodium acetate INJECTABLE;INJECTION 214805 ANDA Woodward Pharma Services LLC 69784-230 69784-230-20 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (69784-230-20)
SODIUM ACETATE sodium acetate INJECTABLE;INJECTION 214805 ANDA Woodward Pharma Services LLC 69784-231 69784-231-20 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (69784-231-20)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2MEQ/ML
Approval Date:May 4, 2021TE:APRLD:No
Regulatory Exclusivity Expiration:Jan 3, 2022
Regulatory Exclusivity Use:COMPETITIVE GENERIC THERAPY

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