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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 078431

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NDA 078431 describes CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare, Baxter Hlthcare Corp, Bedford, Hikma Farmaceutica, Hospira, Inforlife, and Teva Pharms, and is included in seven NDAs. It is available from three suppliers. Additional details are available on the CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER profile page.

The generic ingredient in CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER is ciprofloxacin. There are thirty-four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the ciprofloxacin profile page.

Summary for 078431

Tradename:	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Applicant:	Hikma Farmaceutica
Ingredient:	ciprofloxacin
Patents:	0

Medical Subject Heading (MeSH) Categories for 078431

Anti-Bacterial Agents
Cytochrome P-450 CYP1A2 Inhibitors
Topoisomerase II Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	400MG/200ML
Approval Date:	Nov 18, 2009	TE:	AP	RLD:	No

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