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Last Updated: April 13, 2024

Details for New Drug Application (NDA): 018801


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NDA 018801 describes STERILE WATER FOR INJECTION, which is a drug marketed by Am Regent, Fresenius Kabi Usa, Hikma, Hospira, Medefil Inc, Nephron, Nexus, B Braun, Baxter Hlthcare, Icu Medical Inc, and Taro, and is included in fifteen NDAs. It is available from seventeen suppliers. Additional details are available on the STERILE WATER FOR INJECTION profile page.

The generic ingredient in STERILE WATER FOR INJECTION 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 018801
Tradename:STERILE WATER FOR INJECTION
Applicant:Hospira
Ingredient:sterile water for injection
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 018801
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
STERILE WATER FOR INJECTION sterile water for injection LIQUID;N/A 018801 NDA Henry Schein, Inc. 0404-9959 0404-9959-10 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9959-10) / 10 mL in 1 VIAL, SINGLE-DOSE
STERILE WATER FOR INJECTION sterile water for injection LIQUID;N/A 018801 NDA Henry Schein, Inc. 0404-9959 0404-9959-20 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9959-20) / 20 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:LIQUID;N/AStrength100% (1ML)
Approval Date:Oct 27, 1982TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:LIQUID;N/AStrength100% (10ML)
Approval Date:Oct 27, 1982TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:LIQUID;N/AStrength100% (20ML)
Approval Date:Oct 27, 1982TE:APRLD:Yes

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