Drug Master Files for: Otsuka

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Otsuka Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10257	I	II	5/20/1993	OTSUKA PHARMACEUTICAL CO LTD	FORMULATION RESEARCH INSTITUTE IN TOKUSHIMA, JAPAN
12418	I	II	3/1/1997	OTSUKA PHARMACEUTICAL CO LTD	NADIFLOXACIN DRUG SUBSTANCE
13285	I	II	10/15/1998	OTSUKA PHARMACEUTICAL CO LTD	NO-1886 DRUG SUBSTANCE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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