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NDA

MOXIFLOXACIN HYDROCHLORIDE | N021085 | BAYER HEALTHCARE PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

347 trials from ClinicalTrials.gov — 5 recruiting, 1 active, 296 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Optimizing the Antibiotic Treatment of Uncomplicated Acute Appendicitis NCT03236961	N/A	Active	Turku University Hospital	552	2017-04-03 → 2029-04-01
Safety and Efficacy of Intracameral Zimoxin for Prevention of Endophthalmitis After Cataract Surgery NCT03244072	Phase 2/3	Not Yet Recruiting	Jason Ahee, M.D.	60,000	2026-06-01 → 2031-10
Finding the Optimal Regimen for Mycobacterium Abscessus Treatment NCT04310930	Phase 2/3	Recruiting	The University of Queensland	300	2020-03-02 → 2030-06-30
The Efficacy of the 7 Days Tailored Therapy as the 1st Eradication of H. Pylori Infection NCT02373280	N/A	Recruiting	Seoul National University Bundang Hospital	600	2014-08 → 2027-12
A Trial Evaluating Patient Preference of Dropless vs Drops Post Cataract Surgery NCT04205916	Phase 4	Recruiting	Ophthalmic Consultants of Long Island	50	2019-11-04 → 2020-12-01
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia NCT02735707	Phase 3	Recruiting	UMC Utrecht	20,000	2016-04-11 → 2028-02
A Study to Evaluate the Effect of Volanesorsen on Cardiac Repolarization Conducted in Healthy Volunteers NCT02910635	Phase 1	Completed	Ionis Pharmaceuticals, Inc.	52	2016-09-19 → 2016-12-20
A Double-Blind Study in Healthy Volunteers to Assess the Effect of E7080 on the QTc Interval NCT01525394	Phase 1	Completed	Eisai Inc.	52	2010-12
Shortening Treatment by Advancing Novel Drugs NCT02342886	Phase 3	Completed	Global Alliance for TB Drug Development	284	2015-02 → 2018-05
Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis NCT02595359	Phase 2	Completed	Universidade Federal de Pernambuco	1,000	2013-01 → 2018-06-20

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain20 active DMFs5 inactive

17 active API suppliers hold Drug Master Files for this ingredient.

DR REDDYS LABORATORIES LTDMOXIFLOXACIN HYDROCHLORIDE USP

DMF 169992003

NEULAND LABORATORIES LTDMOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE USP

DMF 187892005

MSN PHARMACHEM PRIVATE LTDMOXIFLOXACIN HYDROCHLORIDE USP (MONOHYDRATE) [ROUTE CODE - "MM"]

DMF 207552007

OLON SPAMOXIFLOXACIN HYDROCHLORIDE

DMF 237452010

MSN PHARMACHEM PRIVATE LTDMOXIFLOXACIN HYDROCHLORIDE USP (ANHYDROUS) [ROUTE CODE: "MP"]

DMF 240032010

APITORIA PHARMA PRIVATE LTDMOXIFLOXACIN HYDROCHLORIDE USP (NON STERILE DRUG SUBSTANCE)

DMF 243712010

UNIMARK REMEDIES LTDMOXIFLOXACIN HYDROCHLORIDE USP

DMF 253622011

SHARON BIO MEDICINE LTDMOXIFLOXACIN HYDROCHLORIDE USP

DMF 259302012

HETERO DRUGS LTDMOXIFLOXACIN HYDROCHLORIDE

DMF 260742012

HETERO DRUGS LTDMOXIFLOXACIN HYDROCHLORIDE ANHYDROUS

DMF 265252012

HEC PHARM CO LTDMOXIFLOXACIN HYDROCHLORIDE NON-STERILE BULK DRUG SUBSTANCE

DMF 273942013

MACLEODS PHARMACEUTICALS LTDMOXIFLOXACIN HYDROCHLORIDE

DMF 293732015

CHROMO LABORATORIES INDIA PRIVATE LTDMOXIFLOXACIN HYDROCHLORIDE USP

DMF 317202019

INNOVARE LABS PRIVATE LTDMOXIFLOXACIN HYDROCHLORIDE USP

DMF 352712020

REYOUNG CORPORATIONMOXIFLOXACIN HYDROCHLORIDE

DMF 355572021

ZHEJIANG GUOBANG PHARMACEUTICAL CO LTDMOXIFLOXACIN HYDROCHLORIDE

DMF 381152023

ZHEJIANG SHAXING TECHNOLOGY CO LTDMOXIFLOXACIN HYDROCHLORIDE

DMF 390202023

NEWLAND PHARMACEUTICAL CO LTDMOXIFLOXACIN HYDROCHLORIDE

DMF 418082025

SHANKUS PHARMA PRIVATE LTDMOXIFLOXACIN HYDROCHLORIDE EP BP

DMF 425332025

SHANKUS PHARMA PRIVATE LTDMOXIFLOXACIN HYDROCHLORIDE USP

DMF 425362025

MYLAN LABORATORIES LTDInactiveMOXIFLOXACIN HYDROCHLORIDE

DMF 170002003

CIPLA LTDInactiveMOXIFLOXACIN HYDROCHLORIDE PH. EUR.

DMF 201702008

ITF CHEMICAL LTDAInactiveMOXIFLOXACIN HYDROCHLORIDE

DMF 233152009

ALP PHARM BEIJING CO LTDInactiveMOXIFLOXACIN HYDROCHLORIDE

DMF 253682011

HISUN PHARMACEUTICAL NANTONG CO LTDInactiveMOXIFLOXACIN HYDROCHLORIDE USP

DMF 285972014

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

40 letters from Drugs@FDA

Date	Submission	Document
Jul 14, 2025	SUPPL -69	View Letter (PDF)
May 7, 2020	SUPPL -66	View Letter (PDF)
May 6, 2019	SUPPL -65	View Letter (PDF)
Oct 23, 2018	SUPPL -64	View Letter (PDF)
Sep 30, 2016	SUPPL -62	View Letter (PDF)
Sep 30, 2016	SUPPL -61	View Letter (PDF)
Jul 26, 2016	SUPPL -63	View Letter (PDF)
May 13, 2015	SUPPL -60	View Letter (PDF)
Nov 24, 2014	SUPPL -59	View Letter (PDF)
Aug 16, 2013	SUPPL -57	View Letter (PDF)
Dec 26, 2012	SUPPL -56	View Letter (PDF)
Aug 28, 2012	SUPPL -55	View Letter (PDF)
Oct 20, 2011	SUPPL -53	View Letter (PDF)
Oct 20, 2011	SUPPL -50	View Letter (PDF)
Aug 8, 2011	SUPPL -52	View Letter (PDF)
Mar 2, 2011	SUPPL -47	View Letter (PDF)
Nov 2, 2010	SUPPL -44	View Letter (PDF)
Apr 9, 2010	SUPPL -46	View Letter (PDF)
Jan 25, 2010	SUPPL -45	View Letter (PDF)
Jun 29, 2009	SUPPL -41	View Letter (PDF)
May 5, 2009	SUPPL -42	View Letter (PDF)
Dec 31, 2008	SUPPL -39	View Letter (PDF)
Oct 7, 2008	SUPPL -40	View Letter (PDF)
Feb 20, 2008	SUPPL -38	View Letter (PDF)
Jun 4, 2007	SUPPL -36	View Letter (PDF)
Nov 30, 2005	SUPPL -27	View Letter (PDF)
Nov 30, 2005	SUPPL -29	View Letter (PDF)
Jun 14, 2005	SUPPL -26	View Letter (PDF)
Jul 30, 2004	SUPPL -24	View Letter (PDF)
May 26, 2004	SUPPL -22	View Letter (PDF)
Mar 10, 2004	SUPPL -23	View Letter (PDF)
Oct 6, 2003	SUPPL -19	View Letter (PDF)
Mar 10, 2003	SUPPL -14	View Letter (PDF)
Mar 10, 2003	SUPPL -15	View Letter (PDF)
Mar 10, 2003	SUPPL -17	View Letter (PDF)
Jun 12, 2002	SUPPL -6	View Letter (PDF)
Jun 12, 2002	SUPPL -7	View Letter (PDF)
May 16, 2002	SUPPL -12	View Letter (PDF)
Apr 27, 2001	SUPPL -10	View Letter (PDF)
Dec 10, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 10, 1999

No patent or exclusivity listings for this strength.