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Last Updated: May 29, 2024

Details for New Drug Application (NDA): 017428

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NDA 017428 describes STERILE WATER, which is a drug marketed by Baxter Hlthcare, Am Regent, Fresenius Kabi Usa, Hikma, Hospira, Medefil Inc, Nephron, Nexus, B Braun, Icu Medical Inc, Taro, and Miles, and is included in twenty-one NDAs. It is available from one supplier. Additional details are available on the STERILE WATER profile page.

The generic ingredient in STERILE WATER is sterile water for injection. There are one thousand and seventy-two drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the sterile water for injection profile page.
Summary for 017428
Applicant:Baxter Hlthcare
Ingredient:sterile water for irrigation
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 017428
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
STERILE WATER sterile water for irrigation LIQUID;IRRIGATION 017428 NDA Baxter Healthcare Corporation 0338-0004 0338-0004-02 24 BOTTLE, PLASTIC in 1 CARTON (0338-0004-02) / 250 mL in 1 BOTTLE, PLASTIC
STERILE WATER sterile water for irrigation LIQUID;IRRIGATION 017428 NDA Baxter Healthcare Corporation 0338-0004 0338-0004-03 18 BOTTLE, PLASTIC in 1 CARTON (0338-0004-03) / 500 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:LIQUID;IRRIGATIONStrength100%
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:Yes

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