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Generated: May 22, 2017

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Details for New Drug Application (NDA): 206369

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NDA 206369 describes STERILE WATER FOR INJECTION, which is a drug marketed by West-ward Pharms Int, Fresenius Kabi Usa, Hospira, Baxter Hlthcare, B Braun, Icu Medcl, and Taro, and is included in nine NDAs. It is available from one supplier. 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 nineteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the sterile water for injection profile page.

Summary for NDA: 206369

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
LIQUID;N/A 206369 ANDA West-Ward Pharmaceuticals Corp. 0641-6147 0641-6147-25 25 VIAL in 1 CARTON (0641-6147-25) > 10 mL in 1 VIAL (0641-6147-01)

Summary for product number 001

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

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