Drug Master Files for: ofloxacin

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ofloxacin 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
10353	A	II	7/13/1993	BAYER AG	CIPROFLOXACIN HYDRATED DRUG SUBSTANCE
10922	I	II	5/25/1994	NORAMCO INC	OFLOXACIN
11602	I	II	2/5/1996	UNION QUIMICO FARMACEUTICA SA	CIPROFLOXACIN HYDROCHLORIDE
11966	A	II	2/21/1996	QUIMICA SINTETICA SA	CIPROFLOXACIN HYDROCHLORIDE (NEW SYNTHETIC PATHWAY)
13072	I	II	7/13/1998	SUN PHARMACEUTICAL INDUSTRIES LTD	CIPROFLOXACIN HYDROCHLORIDE USP
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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