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Last Updated: November 22, 2024

Drug Master Files for: doxercalciferol


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doxercalciferol Drug Master Files

DMF No. Status Type Submission Date Holder Subject
15357 A II 4/12/2001 TEVA PHARMACEUTICAL INDUSTRIES LTD DOXERCALCIFEROL DRUG SUBSTANCE
15397 I II 4/19/2001 CEDARBURG PHARMACEUTICALS LLC DOXERCALCIFEROL
22120 A II 10/27/2008 SAI LIFE SCIENCES LTD DOXERCALCIFEROL USP
22136 A II 10/31/2008 FORMOSA LABORATORIES INC DOXERCALCIFEROL
22590 A II 3/5/2009 POLYMED THERAPEUTICS INC DOXERCALCIFEROL DRUG SUBSTANCE
23233 A II 4/7/2010 LUPIN LTD DOXERCALCIFEROL
25148 A II 3/4/2011 ALP PHARM BEIJING CO LTD DOXERCALCIFEROL
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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