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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
AstraZeneca
Deloitte
Mallinckrodt
Fish and Richardson
Medtronic
Healthtrust
UBS
McKesson

Generated: July 18, 2018

DrugPatentWatch Database Preview

Drug Master Files for: guaifenesin

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guaifenesin Drug Master Files

DMF No. Status Type Submission Date Holder Subject
2502 I II 7/28/1975 GANES CHEMICALS INC PENNSVILLE DIV GUAIFENESIN GLYCERYLGUAIACOLATE
3493 I I 3/14/1979 LEE LABS INC FACILS., CONTROLS & PERSONNEL AT PETERSBURG PLANT FOR GUAIFENESIN
4866 I II 3/8/1983 PEBOC LTD GUAIFENESIN USP
4989 I II 6/28/1983 RHODIA OPERATIONS GUAIFENESIN (GLYCEROL GUAIACOLATE)
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Moodys
Chinese Patent Office
Medtronic
Cipla
Merck
Fish and Richardson
Queensland Health
Fuji
McKinsey

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