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Generated: April 25, 2017

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Details for New Drug Application (NDA): 019869

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NDA 019869 describes STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, which is a drug marketed by Fresenius Kabi Usa, Hospira, Baxter Hlthcare, B Braun, Icu Medcl, and Taro Pharms Ireland, and is included in eight NDAs. It is available from eight 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 nineteen 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: 019869

Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 019869

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
sterile water for injection
LIQUID;N/A 019869 NDA Hospira, Inc. 0409-7118 0409-7118-07 6 BAG in 1 CASE (0409-7118-07) > 2000 mL in 1 BAG

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:LIQUID;N/AStrength100%
Approval Date:Dec 26, 1989TE:APRLD:Yes

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