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Last Updated: September 26, 2022

Details for New Drug Application (NDA): 206369


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NDA 206369 describes STERILE WATER FOR INJECTION, which is a drug marketed by Fresenius Kabi Usa, Hikma, Hospira, Medefil Inc, Nephron, B Braun, Baxter Hlthcare, Icu Medical Inc, and Taro, and is included in twelve NDAs. It is available from twelve 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. Seventeen suppliers are listed for this compound. Additional details are available on the sterile water for injection profile page.
Summary for 206369
Tradename:STERILE WATER FOR INJECTION
Applicant:Hikma
Ingredient:sterile water for injection
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 206369
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 206369 ANDA Hikma Pharmaceuticals USA Inc. 0641-6147 0641-6147-10 10 VIAL in 1 CARTON (0641-6147-10) > 10 mL in 1 VIAL (0641-6147-01)
STERILE WATER FOR INJECTION sterile water for injection LIQUID;N/A 206369 ANDA Hikma Pharmaceuticals USA Inc. 0641-6147 0641-6147-25 25 VIAL in 1 CARTON (0641-6147-25) > 10 mL in 1 VIAL (0641-6147-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:LIQUID;N/AStrength100% (10ML)
Approval Date:Sep 2, 2015TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:LIQUID;N/AStrength100% (20ML)
Approval Date:Sep 2, 2015TE:RLD:No

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