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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 200563

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NDA 200563 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 200563

Tradename:	CIPROFLOXACIN
Applicant:	Chartwell
Ingredient:	ciprofloxacin
Patents:	0

Medical Subject Heading (MeSH) Categories for 200563

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

Suppliers and Packaging for NDA: 200563

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CIPROFLOXACIN	ciprofloxacin	FOR SUSPENSION;ORAL	200563	ANDA	Chartwell RX, LLC	62135-392	62135-392-42	1 KIT in 1 KIT (62135-392-42) * 100 mL in 1 BOTTLE * 100 mL in 1 BOTTLE
CIPROFLOXACIN	ciprofloxacin	FOR SUSPENSION;ORAL	200563	ANDA	Chartwell RX, LLC	62135-393	62135-393-42	1 KIT in 1 KIT (62135-393-42) * 100 mL in 1 BOTTLE * 100 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	250MG/5ML
Approval Date:	Mar 5, 2014	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	500MG/5ML
Approval Date:	Mar 5, 2014	TE:	AB	RLD:	No

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