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Deloitte
US Department of Justice
Mallinckrodt
Merck
Farmers Insurance
Argus Health

Generated: September 19, 2019

DrugPatentWatch Database Preview

Drug Master Files for: topiramate

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topiramate Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10919 A II 5/27/1994 JANSSEN PHARMACEUTICA NV TOPIRAMATE DRUG SUBSTANCE
10978 I II 7/8/1994 CILAG AG TOPIRAMATE
15658 I II 10/8/2001 FERRO PFANSTIEHL LABORATORIES INC TOPIRAMATE
15693 A II 10/31/2001 CIPLA LTD TOPIRAMATE USP
16405 I II 1/30/2003 ALKALOIDA CHEMICAL CO ZRT TOPIRAMATE
16533 A II 3/21/2003 DR REDDYS LABORATORIES LTD TOPIRAMATE USP
17035 A II 12/16/2003 SCINOPHARM TAIWAN LTD TOPIRAMATE USP
>DMF No. >Status >Type >Submission Date >Holder >Subject

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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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Serving hundreds of leading biopharmaceutical companies globally:

US Army
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AstraZeneca

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