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Generated: November 15, 2018

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Details for New Drug Application (NDA): 088400

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NDA 088400 describes STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, which is a drug marketed by B Braun, Baxter Hlthcare, Fresenius Kabi Usa, Hospira, Icu Medical Inc, and Taro, and is included in eight NDAs. It is available from nine suppliers. Additional details are available on the STERILE WATER FOR INJECTION IN PLASTIC CONTAINER profile page.

The generic ingredient in STERILE WATER FOR INJECTION IN PLASTIC CONTAINER is sterile water for injection. There are one thousand and sixty-eight drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the sterile water for injection profile page.
Summary for 088400
Tradename:STERILE WATER FOR INJECTION IN PLASTIC CONTAINER
Applicant:Fresenius Kabi Usa
Ingredient:sterile water for injection
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 088400
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER sterile water for injection LIQUID;N/A 088400 ANDA Fresenius Kabi USA, LLC 63323-185 63323-185-00 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-185-00) > 100 mL in 1 VIAL, SINGLE-DOSE
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER sterile water for injection LIQUID;N/A 088400 ANDA Fresenius Kabi USA, LLC 63323-185 63323-185-05 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-185-05) > 5 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:LIQUID;N/AStrength100%
Approval Date:Jan 16, 1984TE:APRLD:No

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