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Last Updated: May 24, 2020

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Drug Master Files for: CYANOCOBALAMIN


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CYANOCOBALAMIN Drug Master Files

DMF No. Status Type Submission Date Holder Subject
16556 I II 4/24/2003 ANTIBIOTICE SA CYANOCOBALAMIN (VITAMIN B12)
16906 I II 10/15/2003 NORTH CHINA PHARMACEUTICAL VICTOR CO LTD CYANOCOBALAMIN, USP (VITAMIN B-12)
19702 I II 8/14/2006 WOCKHARDT LTD CYANOCOBALAMIN USP
20973 I II 10/25/2007 HEBEI HUARONG PHARMACEUTICAL CO LTD CYANOCOBALAMIN
21391 A II 3/3/2008 HEBEI YUXING BIO ENGINEERING CO LTD CYANOCOBALAMIN
3222 I II 5/23/1978 FARMITALIA SPA CYANOCOBALAMIN (VITAMIN B 12)
4095 A II 2/27/1981 SANOFI CHIMIE CYANOCOBALAMIN
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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