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MOXIFLOXACIN HYDROCHLORIDE

NDA

MOXIFLOXACIN HYDROCHLORIDE | N205572 | FRESENIUS KABI USA LLC

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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

5 letters from Drugs@FDA

Date	Submission	Document
Mar 30, 2020	SUPPL -5	View Letter (PDF)
May 7, 2019	SUPPL -6	View Letter (PDF)
Oct 23, 2018	SUPPL -4	View Letter (PDF)
Jul 26, 2016	SUPPL -2	View Letter (PDF)
Apr 8, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 400MG BASE/250ML (EQ 1.6MG BASE/ML)

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Apr 3, 2015

No patent or exclusivity listings for this strength.