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Generated: June 17, 2019

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Drug Master Files for: NIACIN

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NIACIN 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.
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

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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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