Details for New Drug Application (NDA): 211222

NDA 211222 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 211222

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

Suppliers and Packaging for NDA: 211222

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	211222	ANDA	Nephron Pharmaceuticals Corporation	0487-6105	0487-6105-01	30 VIAL, PLASTIC in 1 CARTON (0487-6105-01) / 5 mL in 1 VIAL, PLASTIC
STERILE WATER FOR INJECTION	sterile water for injection	LIQUID;N/A	211222	ANDA	Chartwell RX, LLC	62135-833	62135-833-84	30 VIAL, SINGLE-DOSE in 1 CARTON (62135-833-84) / 5 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	LIQUID;N/A			Strength	100% (5ML)
Approval Date:	Feb 10, 2021	TE:	AP	RLD:	No

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