Drug Master Files for: niacinamide
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niacinamide Drug Master Files
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. |
11119 | I | II | 9/21/1994 | LONZA LTD | NIACINAMIDE |
14882 | I | II | 5/19/2000 | VERTELLUS AGRICULTURE NUTRITION SPECIALTIES LLC | NIACINAMIDE USP |
30711 | A | II | 6/13/2016 | LONZA AG | NIACINAMIDE FOR ORAL USE |
4787 | I | II | 12/7/1982 | YUKI GOSEI KOGYO CO LTD | NIACINAMIDE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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