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Last Updated: March 28, 2024

Drug Master Files for: argatroban


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argatroban Drug Master Files

DMF No. Status Type Submission Date Holder Subject
20709 A II 7/20/2007 CHEMWERTH INC ARGATROBAN HYDRATE (NON-STERILE BULK) DRUG SUBSTANCE
20760 A II 8/7/2007 EUTICALS SPA ARGATROBAN
21304 A II 1/30/2008 LUNDBECK PHARMACEUTICALS ITALY SPA ARGATROBAN
22855 A II 8/14/2009 CHEMWERTH INC INTERMEDIATE 6 OF ARGATROBAN (ARGA 6)
22935 I II 7/10/2009 SCINOPHARM TAIWAN LTD ARGATROBAN
25400 A II 10/27/2011 GLAND PHARMA LTD ARGATROBAN MONOHYDRATE USP
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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