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Last Updated: March 28, 2024

Drug Master Files for: desloratadine


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desloratadine Drug Master Files

DMF No. Status Type Submission Date Holder Subject
17652 A II 9/7/2004 MOREPEN LABORATORIES LTD DESLORATADINE
19014 A II 12/8/2005 SUN PHARMACEUTICAL INDUSTRIES LTD DESLORATADINE
19083 A II 12/27/2005 LUPIN LTD DESLORATADINE USP
19182 I II 5/18/2006 CIPLA LTD DESLORATADINE
19339 A II 4/11/2006 ORCHID PHARMA LTD DESLORATADINE
19403 A II 5/2/2006 TEVA PHARMACEUTICAL INDUSTRIES LTD DESLORATADINE DRUG SUBSTANCE
19428 A II 5/12/2006 GLENMARK PHARMACEUTICALS LTD DESLORATADINE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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