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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 217536

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NDA 217536 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 sixteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the sterile water for injection profile page.

Summary for 217536

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	LIQUID;N/A			Strength	100% (10ML)
Approval Date:	Jul 11, 2023	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	LIQUID;N/A			Strength	100% (20ML)
Approval Date:	Jul 11, 2023	TE:	AP	RLD:	No

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