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NOROXIN

NDA

NORFLOXACIN | N019384 | 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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Jubilant Generics FDA-2017-P-2659 Jubilant Generics Ltd. filed this petition under 505(b)(7) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine that the discontinuation of NOROXIN (Norfloxacin Tablets, NDA 019384) by Merck Research Laboratories was not for safety or effectiveness reasons, thereby permittin	505(q)	2017-04-28	Open	Jubilant Generics

Source: Regulations.gov. FDA citizen petitions matched by application number.

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.

Approval Letters

24 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#002 — 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Oct 31, 1986

No patent or exclusivity listings for this strength.