Last Updated: June 17, 2026

Details for New Drug Application (NDA): 219475

✉ Email this page to a colleague

« Back to Dashboard

NDA 219475 describes MOXIFLOXACIN HYDROCHLORIDE, which is a drug marketed by Alembic, Apotex, Epic Pharma Llc, Eugia Pharma, Fdc Ltd, Gland, Lupin, Mankind Pharma, Pharmobedient, Regcon Holdings, Somerset Theraps Llc, Upsher Smith Labs, Fresenius Kabi Usa, Aurobindo Pharma Ltd, Chartwell Rx, Crossmedika Sa, Dr Reddys, Hetero Labs Ltd V, Macleods Pharms Ltd, MSN, Natco, Sunshine, Teva Pharms Usa, Torrent, and Mylan Labs Ltd, and is included in twenty-six NDAs. It is available from thirty-two suppliers. Additional details are available on the MOXIFLOXACIN HYDROCHLORIDE profile page.

The generic ingredient in MOXIFLOXACIN HYDROCHLORIDE is moxifloxacin hydrochloride. There are eighteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the moxifloxacin hydrochloride profile page.

Summary for 219475

Tradename:	MOXIFLOXACIN HYDROCHLORIDE
Applicant:	Fdc Ltd
Ingredient:	moxifloxacin hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 0.5% BASE
Approval Date:	Aug 4, 2025	TE:		RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.