Details for New Drug Application (NDA): 088400

NDA 088400 describes STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, which is a drug marketed by B Braun, Baxter Hlthcare, Fresenius Kabi Usa, Otsuka Icu Medcl, and Taro, and is included in seven NDAs. It is available from six suppliers. Additional details are available on the STERILE WATER FOR INJECTION IN PLASTIC CONTAINER profile page.

The generic ingredient in STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 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 088400

Tradename:	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER
Applicant:	Fresenius Kabi Usa
Ingredient:	sterile water for injection
Patents:	0

Suppliers and Packaging for NDA: 088400

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	sterile water for injection	LIQUID;N/A	088400	ANDA	Cardinal Health 107, LLC	55154-9588	55154-9588-5	5 VIAL in 1 BAG (55154-9588-5) / 10 mL in 1 VIAL
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	sterile water for injection	LIQUID;N/A	088400	ANDA	Fresenius Kabi USA, LLC	63323-185	63323-185-05	25 VIAL, SINGLE-DOSE in 1 TRAY (63323-185-05) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-185-04)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	LIQUID;N/A			Strength	100%
Approval Date:	Jan 16, 1984	TE:	AP	RLD:	No

Complete Access Available with Subscription