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Last Updated: November 5, 2024

Details for New Drug Application (NDA): 217341

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NDA 217341 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 fifteen 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. Eighteen suppliers are listed for this compound. Additional details are available on the sterile water for injection profile page.

Summary for 217341

Tradename:	STERILE WATER FOR INJECTION
Applicant:	Am Regent
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:	Aug 29, 2023	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	LIQUID;N/A			Strength	100% (20ML)
Approval Date:	Aug 29, 2023	TE:	AP	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	LIQUID;N/A			Strength	100% (5ML)
Approval Date:	Feb 9, 2024	TE:	AP	RLD:	No

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