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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Express Scripts
Daiichi Sankyo
Johnson and Johnson
Merck
Cantor Fitzgerald
Argus Health
Medtronic
Chubb

Generated: July 21, 2018

DrugPatentWatch Database Preview

Drug Master Files for: dantrolene

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dantrolene Drug Master Files

DMF No. Status Type Submission Date Holder Subject
15167 A II 11/28/2000 JINAN JINDA PHARMACEUTICAL CHEMISTRY CO LTD DANTROLENE SODIUM NON-STERILE BULK DRUG SUBSTANCE
16118 A II 8/23/2002 SCINOPHARM TAIWAN LTD DANTROLENE SODIUM USP
17446 I II 5/27/2004 FDC LTD DANTROLENE SODIUM
19498 A II 6/1/2006 HELSINN CHEMICALS SA HELSINN ADVANCED SYNTHESIS SA DANTROLENE SODIUM DRUG SUBSTANCE
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Medtronic
Moodys
US Army
Mallinckrodt
QuintilesIMS
Fish and Richardson
Dow
McKesson
Cipla

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