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CILOXAN

NDA

CIPROFLOXACIN HYDROCHLORIDE | N020369 | SANDOZ 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 Chain8 active DMFs12 inactive

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

BAYER AGCIPROFLOXACIN HYDROCHLORIDE

DMF 81341989

QUIMICA SINTETICA SACIPROFLOXACIN HYDROCHLORIDE

DMF 119661996

NEULAND LABORATORIES LTDCIPROFLOXACIN HYDROCHLORIDE USP

DMF 132501998

ZHEJIANG HUAYI PHARMACEUTICAL CO LTDCIPROFLOXACIN HYDROCHLORIDE

DMF 180832004

AARTI DRUGS LTDCIPROFLOXACIN HYDROCHLORIDE

DMF 196112006

THINQ PHARMA-CRO LTDCIPROFLOXACIN HYDROCHLORIDE USP

DMF 306162016

TURTLE PHARMA PRIVATE LTDCIPROFLOXACIN HYDROCHLORIDE USP

DMF 332452018

PHLOW CORPCIPROFLOXACIN HYDROCHLORIDE USP

DMF 372062024

QUIMICA SINTETICA SAInactiveCIPROFLOXACIN HYDROCHLORIDE

DMF 85171990

CIPLA LTDInactiveCIPROFLOXACIN HYDROCHLORIDE USP IN BANGALORE, INDIA

DMF 86271990

UNION QUIMICO FARMACEUTICA SAInactiveCIPROFLOXACIN HYDROCHLORIDE

DMF 116021996

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveCIPROFLOXACIN HYDROCHLORIDE USP

DMF 130721998

CIPLA LTDInactiveCIPROFLOXACIN HYDROCHLORIDE USP

DMF 147092000

MYLAN LABORATORIES LTDInactiveCIPROFLOXACIN HYDROCHLORIDE USP

DMF 165442003

UNIQUE CHEMICALSInactiveCIPROFLOXACIN HYDROCHLORIDE USP

DMF 177862004

APITORIA PHARMA PRIVATE LTDInactiveCIPROFLOXACIN HYDROCHLORIDE USP

DMF 185582005

ZHEJIANG XINHUA PHARMACEUTICAL CO LTDInactiveCIPROFLOXACIN HYDROCHLORIDE

DMF 198762006

ZHEJIANG JINGXIN PHARMACEUTICAL CO LTDInactiveCIPROFLOXACIN HYDROCHLORIDE

DMF 203372007

INDOCO REMEDIES LTDInactiveCIPROFLOXACIN HYDROCHLORIDE USP

DMF 219092008

SMRUTHI ORGANICS LTDInactiveCIPROFLOXACIN HYDROCHLORIDE USP

DMF 246362011

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Feb 21, 2017	SUPPL -22	View Letter (PDF)
Jul 21, 2004	SUPPL -9	View Letter (PDF)
Jul 21, 2004	SUPPL -10	View Letter (PDF)
Aug 28, 2003	SUPPL -6	View Letter (PDF)
Aug 28, 2003	SUPPL -7	View Letter (PDF)
Mar 30, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.3% BASE

RLD

0 patents0 exclusivities▴

OINTMENT;OPHTHALMIC | Approved: Mar 30, 1998

No patent or exclusivity listings for this strength.