Drug Master Files for: niacin

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niacin Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10173	I	II	3/8/1993	YUKI GOSEI KOGYO CO LTD	MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF NIACINAMIDE IN JOBAN, IWAKI-CITY, FUKUSHIMA PREFECTURE, JAPAN.
10523	I	II	10/7/1993	UPSHER SMITH LABORATORIES INC	NIACOR (IMMEDIATE-RELEASE NIACIN TABLETS)
11119	I	II	9/21/1994	LONZA LTD	NIACINAMIDE
14882	I	II	5/19/2000	VERTELLUS AGRICULTURE NUTRITION SPECIALTIES LLC	NIACINAMIDE USP
18293	A	II	4/11/2005	LONZA LTD	NIACIN USP GRANULAR SPECIAL
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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