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NDA

LEVOFLOXACIN | N021571 | SANTEN 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

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 Chain23 active DMFs10 inactive

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

CIPLA LTDLEVOFLOXACIN HEMIHYDRATE USP

DMF 158642002

TEVA PHARMACEUTICAL INDUSTRIES LTDLEVOFLOXACIN

DMF 165212003

DR REDDYS LABORATORIES LTDLEVOFLOXACIN HEMIHYDRATE USP

DMF 166582003

CIPLA LTDLEVOFLOXACIN USP

DMF 169222003

MATRIX PHARMACORP PRIVATE LTDLEVOFLOXACIN USP (HEMIHYDRATE)

DMF 175322004

ITF CHEMICAL LTDALEVOFLOXACIN HEMIHYDRATE

DMF 175802004

ZYDUS LIFESCIENCES LTDLEVOFLOXACIN USP (HEMIHYDRATE)

DMF 181182005

HOLIDAY LABS MEXICO SA DE CVLEVOFLOXACIN HEMIHYDRATE

DMF 181592005

NEULAND LABORATORIES LTDLEVOFLOXACIN USP (HEMIHYDRATE)

DMF 188922005

APOTEX PHARMACHEM INDIA PVT LTDLEVOFLOXACIN USP

DMF 194582006

ZHEJIANG APELOA KANGYU PHARMACEUTICAL CO LTDLEVOFLOXACIN HEMIHYDRATE, USP

DMF 195112006

APITORIA PHARMA PRIVATE LTDLEVOFLOXACIN USP (NON-STERILE DRUG SUBSTANCE)

DMF 222652008

MACLEODS PHARMACEUTICALS LTDLEVOFLOXACIN HEMIHYDRATE

DMF 223752008

PH HEALTH LTDLEVOFLOXACIN HEMIHYDRATE (NON-STERILE BULK DRUG SUBSTANCE)

DMF 233822009

ORBION PHARMACEUTICALS PRIVATE LTDLEVOFLOXACIN (NON-STRILE BULK API)

DMF 236392010

HETERO DRUGS LTDLEVOFLOXACIN HEMIHYDRATE, USP

DMF 238652010

HEC PHARM CO LTDLEVOFLOXACIN NON-STERILE BULK DRUG SUBSTANCE

DMF 262952012

ZHEJIANG LANGHUA PHARMACEUTICAL CO LTDLEVOFLOXACIN

DMF 267122012

QUIMICA SINTETICA SALEVOFLOXACIN

DMF 289202014

ZHEJIANG MEDICINE CO LTDLEVOFLOXACIN

DMF 319982017

MSN LIFE SCIENCES PRIVATE LTDLEVOFLOXACIN HEMIHYDRATE USP

DMF 326632018

TURTLE PHARMA PRIVATE LTDLEVOFLOXACIN HEMIHYDRATE USP

DMF 332442018

CHROMO LABORATORIES INDIA PRIVATE LTDLEVOFLOXACIN HEMIHYDRATE USP

DMF 384492024

DAIICHI SANKYO CO LTDInactiveLEVOFLOXACIN DRUG SUBSTANCE

DMF 101021993

QUIMICA SINTETICA SAInactiveLEVOFLOXACIN

DMF 156722001

YUHAN CHEMICAL INCInactiveLEVOFLOXACIN HEMIHYDRATE

DMF 166162003

NEULAND LABORATORIES LTDInactiveLEVOFLOXACIN

DMF 167912003

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveLEVOFLOXACIN USP

DMF 169082003

QUIMICA SINTETICA SAInactiveLEVOFLOXACIN

DMF 194872006

ZHEJIANG JINGXIN PHARMACEUTICAL CO LTDInactiveLEVOFLOXACIN HEMIHYDRATE

DMF 202252007

LUPIN LTDInactiveLEVOFLOXACIN HEMIHYDRATE USP

DMF 229902009

ZHEJIANG MEDICINE CO LTD XINCHANG PHARMACEUTICAL FACTORYInactiveLEVOFLOXACIN DS

DMF 246602011

SHAOXING JINGXIN PHARMACEUTICALS CO LTDInactiveLEVOFLOXACIN HEMIHYDATE

DMF 392122023

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Dec 4, 2014	SUPPL -6	View Letter (PDF)
Mar 2, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Mar 1, 2004

No patent or exclusivity listings for this strength.