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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Mallinckrodt
Argus Health
Farmers Insurance
Chinese Patent Office
Johnson and Johnson
McKesson
Boehringer Ingelheim
Citi

Generated: July 16, 2018

DrugPatentWatch Database Preview

Drug Master Files for: palonosetron

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palonosetron Drug Master Files

DMF No. Status Type Submission Date Holder Subject
16063 A II 7/19/2002 HELSINN ADVANCED SYNTHESIS SA PALONOSETRON HYDROCHLORIDE USP
18187 A II 3/17/2005 CATALENT PHARMA SOLUTIONS LLC PALONOSETRON HYDROCHLORIDE 0.50 MG SOFTGELS
21123 A II 12/11/2007 NEULAND LABORATORIES LTD PALONOSETRON HYDROCHLORIDE
21749 A II 7/1/2008 TEVA PHARMACEUTICAL INDUSTRIES LTD PALONOSETRON 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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Citi
Queensland Health
Daiichi Sankyo
Boehringer Ingelheim
Johnson and Johnson
Cipla
Colorcon
Chubb
McKinsey

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