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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 078183

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NDA 078183 describes CIPROFLOXACIN EXTENDED RELEASE, which is a drug marketed by Ani Pharms, Dr Reddys Labs Ltd, Fosun Pharma, Ph Health, and Rising, and is included in five NDAs. Additional details are available on the CIPROFLOXACIN EXTENDED RELEASE profile page.

The generic ingredient in CIPROFLOXACIN EXTENDED RELEASE is ciprofloxacin; ciprofloxacin hydrochloride. There are thirty-four drug master file entries for this compound. Additional details are available on the ciprofloxacin; ciprofloxacin hydrochloride profile page.

Summary for 078183

Tradename:	CIPROFLOXACIN EXTENDED RELEASE
Applicant:	Rising
Ingredient:	ciprofloxacin; ciprofloxacin hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	212.6MG;EQ 287.5MG BASE
Approval Date:	Mar 22, 2007	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	425.2MG;EQ 574.9MG BASE
Approval Date:	Mar 22, 2007	TE:		RLD:	No

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