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Details for New Drug Application (NDA): 017428

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NDA 017428 describes STERILE WATER, which is a drug marketed by Baxter Hlthcare, Eurohlth Intl Sarl, Fresenius Kabi Usa, Hospira, B Braun, Taro Pharms Ireland, and Miles, and is included in fifteen 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 fifteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the sterile water for injection profile page.

Summary for NDA: 017428

Tradename:
STERILE WATER
Applicant:
Baxter Hlthcare
Ingredient:
sterile water for irrigation
Patents:0
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:LIQUID;IRRIGATIONStrength100%
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:No


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