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CHIBROXIN

NDA

NORFLOXACIN | N019757 | MERCK RESEARCH LABORATORIES DIV MERCK CO 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 Chain0 active DMFs7 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

KYORIN PHARMACEUTICAL CO LTDInactiveNORFLOXACIN

DMF 51951983

CIPLA LTDInactiveNORFLOXACIN

DMF 84151990

QUIMICA SINTETICA SAInactiveNORFLOXACIN USP XXII

DMF 84901990

CHINA CHEMICAL SYNTHESIS INDUSTRIAL CO LTDInactiveNORFLOXACIN

DMF 93601991

WYCKOFF CHEMICAL CO INCInactiveNORFLOXACIN

DMF 111391994

CIPLA LTDInactiveNORFLOXACIN USP

DMF 118111996

SMRUTHI ORGANICS LTDInactiveNORFLOXACIN USP

DMF 190212005

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

Products (1)

#001 — 0.3%

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Jun 17, 1991

No patent or exclusivity listings for this strength.