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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 076992

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NDA 076992 describes CIPROFLOXACIN, which is a drug marketed by Chartwell, Baxter Hlthcare Corp, Bedford Labs, Dr Reddys, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Amneal, Sentiss, Sun Pharm, Ani Pharms, Dr Reddys Labs Ltd, Fosun Pharma, Ph Health, Rising, Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Pharmobedient, Rubicon Research, The J Molner, Watson Labs Inc, New Heightsrx, Aiping Pharm Inc, Aurobindo Pharma, Barr, Carlsbad, Hikma, Ivax Sub Teva Pharms, Natco, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro, Teva, Unique, Watson Labs, Yiling, Cosette Pharms Nc, Baxter Hlthcare, Bedford, Inforlife, and Teva Pharms, and is included in fifty-four NDAs. It is available from one supplier. Additional details are available on the CIPROFLOXACIN profile page.

The generic ingredient in CIPROFLOXACIN is ciprofloxacin hydrochloride; hydrocortisone. 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 hydrochloride; hydrocortisone profile page.

Summary for 076992

Tradename:	CIPROFLOXACIN
Applicant:	Bedford Labs
Ingredient:	ciprofloxacin
Patents:	0

Medical Subject Heading (MeSH) Categories for 076992

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	200MG/20ML (10MG/ML)
Approval Date:	Aug 28, 2006	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	400MG/40ML (10MG/ML)
Approval Date:	Aug 28, 2006	TE:		RLD:	No

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