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Serving leading biopharmaceutical companies globally:

Medtronic
Healthtrust
Boehringer Ingelheim
QuintilesIMS
Harvard Business School
Fuji
Deloitte
Queensland Health
McKesson
Dow

Generated: December 11, 2017

DrugPatentWatch Database Preview

Drug Master Files for: dexmedetomidine

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DMF No. Status Type Submission Date Holder Subject
9251III7/18/1991ORION CORP LTDDEXMEDETOMIDINE
9303III8/23/1991CYGNUS THERAPEUTIC SYSTEMSDEXMEDETOMIDINE TRANSDERMAL SYSTEM (DEXMED TX) REDWOOD CITY, CA.
13810AII10/30/1998FERMION OYDEXMEDETOMIDINE HYDROCHLORIDE
22681AII3/31/2009ALCAMI WISCONSIN CORPDEXMEDETOMIDINE HYDROCHLORIDE USP (FP-071)
23132AII9/28/2009RELIABLE BIOPHARMACEUTICAL LLCDEXMEDETOMIDINE HCI
24202AII12/15/2011CHEMWERTH INCDEXMEDETOMIDINE HCL
26223AII7/16/2012ASYMCHEM LABORATORIES TIANJIN CO LTDDEXMEDETOMIDINE HYDROCHLORIDE
26377AII9/4/2012JIANGSU HENGRUI MEDICINE CO LTDDEXMEDETOMIDINE HYDROCHLORIDE USP, NON-STERILE, BULK DRUG SUBSTANCE
26984AII3/12/2013EDMOND PHARMA SRLDEXMEDETOMIDINE HCI
27883AII1/6/2014INTERQUIM SA DE CVDEXMEDETOMIDINE HYDROCHLORIDE
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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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 leading biopharmaceutical companies globally:

Queensland Health
Citi
Fuji
QuintilesIMS
Fish and Richardson
McKesson
Medtronic
Accenture
US Army
AstraZeneca

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