Drug Master Files for: LEVOFLOXACIN

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LEVOFLOXACIN Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10102	A	II	2/26/1993	DAIICHI SANKYO CO LTD	LEVOFLOXACIN DRUG SUBSTANCE
15672	A	II	10/15/2001	QUIMICA SINTETICA SA	LEVOFLOXACIN
15864	A	II	2/15/2002	CIPLA LTD	LEVOFLOXACIN HEMIHYDRATE USP
16521	A	II	4/7/2003	TEVA PHARMACEUTICAL INDUSTRIES LTD	LEVOFLOXACIN
16616	I	II	5/29/2003	YUHAN CHEMICAL INC	LEVOFLOXACIN HEMIHYDRATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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