Drug Master Files for: DAPSONE

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DAPSONE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
15065	A	II	9/29/2000	LUNDBECK PHARMACEUTICALS ITALY SPA	DAPSONE
17781	A	II	10/28/2004	ATUL LTD	DAPSONE USP
25089	I	II	6/29/2011	REGIS TECHNOLOGIES INC	DAPSONE, USP
27678	A	II	12/13/2013	NOVITIUM PHARMA LLC	DAPSONE USP
27701	A	II	11/6/2013	SAI LIFE SCIENCES LTD	DAPSONE USP
29999	A	II	3/31/2016	TARO PHARMACEUTICAL INDUSTRIES LTD	DAPSONE USP
31521	A	II	6/22/2017	DIPHARMA FRANCIS SRL	DAPSONE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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