Last Updated: November 8, 2026

Details for New Drug Application (NDA): 077701

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NDA 077701 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 is one drug master file entry for this compound. Additional details are available on the ciprofloxacin; ciprofloxacin hydrochloride profile page.

Summary for 077701

Tradename:	CIPROFLOXACIN EXTENDED RELEASE
Applicant:	Dr Reddys Labs Ltd
Ingredient:	ciprofloxacin; ciprofloxacin hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	425.2MG;EQ 574.9MG BASE
Approval Date:	Mar 26, 2007	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	212.6MG;EQ 287.5MG BASE
Approval Date:	Oct 31, 2007	TE:		RLD:	No

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