Last Updated: September 24, 2026

Details for New Drug Application (NDA): 212735

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NDA 212735 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, Otsuka Icu Medcl, 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 is one drug master file entry for this compound. Twenty suppliers are listed for this compound. Additional details are available on the sterile water for injection profile page.

Summary for 212735

Tradename:	STERILE WATER FOR INJECTION
Applicant:	Hikma
Ingredient:	sterile water for injection
Patents:	0

Suppliers and Packaging for NDA: 212735

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	212735	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9339	0143-9339-12	12 BAG in 1 CASE (0143-9339-12) / 1000 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	LIQUID;N/A			Strength	100%
Approval Date:	Jan 31, 2023	TE:	AP	RLD:	No

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