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Serving leading biopharmaceutical companies globally:

Argus Health
Healthtrust
AstraZeneca
Fish and Richardson
Merck
Queensland Health
Farmers Insurance
Accenture
Moodys
US Department of Justice

Generated: October 20, 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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Boehringer Ingelheim
Novartis
Deloitte
Dow
Chinese Patent Office
Covington
Johnson and Johnson
Cerilliant
Accenture
AstraZeneca

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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