Drug Master Files for: MOXIFLOXACIN HYDROCHLORIDE

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MOXIFLOXACIN HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
16999	A	II	12/2/2003	DR REDDYS LABORATORIES LTD	MOXIFLOXACIN HYDROCHLORIDE USP
17000	I	II	12/3/2003	MYLAN LABORATORIES LTD	MOXIFLOXACIN HYDROCHLORIDE
18789	A	II	9/19/2005	NEULAND LABORATORIES LTD	MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE USP
20170	I	II	7/31/2008	CIPLA LTD	MOXIFLOXACIN HYDROCHLORIDE PH. EUR.
20755	A	II	8/3/2007	MSN PHARMACHEM PRIVATE LTD	MOXIFLOXACIN HYDROCHLORIDE USP (MONOHYDRATE) [ROUTE CODE - MM]
23315	I	II	11/27/2009	ITF CHEMICAL LTDA	MOXIFLOXACIN HYDROCHLORIDE
>DMF No.	>Status	>Type	>Submission Date	>Holder	>Subject

Drug Master File Glossary

STATUS OF DMFS

A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
I = Inactive
N = Not an assigned number
P = DMF Pending Filing Review

TYPES OF DMFs

Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
Type III Packaging Material
Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
Type V FDA Accepted Reference Information

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