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Last Updated: March 29, 2024

Drug Master Files for: TAMOXIFEN CITRATE


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TAMOXIFEN CITRATE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10681 I II 12/15/1993 CHEMICAL PHARMACEUTICAL RESEARCH INSTITUTE NIHFI LTD TAMOXIFEN CITRATE
15121 I II 10/31/2000 EGIS PHARMACEUTICALS PRIVATE LTD TAMOXIFEN CITRATE BULK
19284 I II 3/8/2006 YANGTZE RIVER PHARMACY GROUP JIANGSU HAI CI BIOLOGICAL PHARMACY CO LTD TAMOXIFEN CITRATE USP
21757 I II 6/5/2008 OLON SPA TAMOXIFEN CITRATE
27466 A II 8/26/2013 ASYMCHEM LABORATORIES TIANJIN CO LTD TAMOXIFEN CITRATE
4734 I II 12/1/1982 LEIRAS PHARMACEUTICALS TAMOXIFEN CITRATE TABLETS
4793 I II 1/12/1983 LEIRAS PHARMACEUTICALS TAMOXIFEN CITRATE, BULK FORM
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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