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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Queensland Health
QuintilesIMS
Moodys
Colorcon
Harvard Business School
Cerilliant
Covington
US Department of Justice

Generated: June 25, 2018

DrugPatentWatch Database Preview

Drug Master Files for: cyclobenzaprine

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cyclobenzaprine Drug Master Files

DMF No. Status Type Submission Date Holder Subject
5810 I II 5/7/1985 GANES CHEMICALS INC PENNSVILLE DIV CYCLOBENZAPRINE HYDROCHLORIDE
5827 A II 5/10/1985 MEDICHEM SA CYCLOBENZAPRINE HCL
5864 A II 6/6/1985 DIPHARMA FRANCIS SRL CYCLOBENZAPRINE HCL
7759 I II 10/28/1988 FERMION OY CYCLOBENZAPRINE HCL
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

AstraZeneca
Teva
Johnson and Johnson
Boehringer Ingelheim
Citi
McKinsey
Chubb
Deloitte
Argus Health

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