Drug Master Files for: CLOFAZIMINE

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CLOFAZIMINE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
16668	A	II	6/26/2003	SANDOZ PRIVATE LTD	CLOFAZIMINE
25326	I	II	9/28/2011	SANGROSE LABORATORIES PVT LTD	CLOFAZIMINE
31256	A	II	12/21/2016	ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD	CLOFAZIMINE USP
33157	A	II	9/6/2018	OLON SPA	CLOFAZIMINE
3527	I	II	5/4/1979	CIBA GEIGY CORP PHARMACEUTICAL DIVISION	LAMPRENE (CLOFAZIMINE) AS PRODUCED IN CAPSULE FORM
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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