Drug Master Files for: dutasteride

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dutasteride Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
14643	I	II	12/22/1999	CATALENT FRANCE BEINHEIM SA	DUTASTERIDE SOFT GELATIN CAPSULES .5MG
18408	I	II	6/7/2005	DR REDDYS LABORATORIES LTD	DUTASTERIDE (Process-I)
20180	A	II	5/6/2009	CIPLA LTD	DUTASTERIDE
20918	A	II	10/8/2007	STERLING SPA	DUTASTERIDE
23494	I	II	4/30/2010	FIS FABBRICA ITALIANA SINTETICI SPA	DUTASTERIDE
23533	A	II	2/16/2010	MSN LABORATORIES PRIVATE LTD	DUTASTERIDE USP [ROUTE CODE - DT]
23810	A	II	5/18/2010	GADOR SA	DUTASTERIDE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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