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Baxter
Johnson and Johnson
Medtronic
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AstraZeneca
Harvard Business School

Last Updated: October 23, 2019

DrugPatentWatch Database Preview

Drug Master Files for: ROTIGOTINE

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ROTIGOTINE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
25863 I II 3/7/2012 OLON SPA ROTIGOTINE
26236 A II 7/12/2012 WAVELENGTH ENTERPRISES LTD ROTIGOTINE
26481 A II 9/26/2012 INTERQUIM SA ROTIGOTINE
27370 A II 8/30/2013 MYLAN LABORATORIES LTD ROTIGOTINE
27554 A II 9/13/2013 OLON USA INC ROTIGOTINE POLYMORPH II
29468 A II 6/30/2015 TEVA PHARMACEUTICAL INDUSTRIES LTD ROTIGOTINE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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Serving leading biopharmaceutical companies globally:

AstraZeneca
McKesson
Colorcon
Johnson and Johnson
Baxter
McKinsey

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