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FACTIVE

NDA

GEMIFLOXACIN MESYLATE | N021158 | LG CHEM LTD

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain2 active DMFs1 inactive

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

ORBION PHARMACEUTICALS PRIVATE LTDGEMIFLOXACIN MESYLATE (NON-STERILE BULK API)

DMF 212382008

MAITHRI DRUGS PRIVATE LTDGEMIFLOXACIN MESYLATE USP

DMF 378972023

LG CHEM LTDInactiveGEMIFLOXACIN MESYLATE

DMF 145241999

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

Approval Letters

16 letters from Drugs@FDA

Date	Submission	Document
May 7, 2019	SUPPL -26	View Letter (PDF)
Dec 20, 2018	SUPPL -24	View Letter (PDF)
Oct 23, 2018	SUPPL -25	View Letter (PDF)
Jul 26, 2016	SUPPL -23	View Letter (PDF)
Aug 16, 2013	SUPPL -22	View Letter (PDF)
Oct 20, 2011	SUPPL -21	View Letter (PDF)
Mar 3, 2011	SUPPL -18	View Letter (PDF)
May 4, 2009	SUPPL -14	View Letter (PDF)
Oct 8, 2008	SUPPL -12	View Letter (PDF)
Jan 9, 2008	SUPPL -11	View Letter (PDF)
May 7, 2007	SUPPL -7	View Letter (PDF)
Nov 6, 2006	SUPPL -5	View Letter (PDF)
Sep 10, 2004	SUPPL -3	View Letter (PDF)
Jul 30, 2004	SUPPL -2	View Letter (PDF)
Aug 15, 2003	SUPPL -1	View Letter (PDF)
Apr 18, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 320MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 4, 2003

No patent or exclusivity listings for this strength.