Viewing data from:

GEMIFLOXACIN MESYLATE

ANDA

GEMIFLOXACIN MESYLATE | A090466 | ORBION PHARMACEUTICALS PRIVATE LTD

1 strength0 unique patents0 unique exclusivities

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

1 letter from Drugs@FDA

Date	Submission	Document
Jun 18, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 320MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 15, 2015

No patent or exclusivity listings for this strength.