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Last Updated: April 26, 2024

Drug Master Files for: Santen

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Santen Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10927	I	II	6/3/1994	SANTEN PHARMACEUTICAL CO LTD	MANUFACTURING PLANT AT NOTO, JAPAN
14320	I	II	7/29/1999	SANTEN PHARMACEUTICAL CO LTD	CS-011 DRUG SUBSTANCE
16643	I	V	6/12/2003	SANTEN OY	STERILIZATION PROCESS FOR CONTINUOUS MOTION (CM1) COMPOUNDING AND FILLING LINE
3446	I	II	2/6/1979	SANTEN PHARMACEUTICAL CO LTD	THIOLA
5257	I	II	5/11/1983	SANTEN PHARMACEUTICAL CO LTD	TROPICAMIDE MYDRIATIC
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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