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Generated: November 13, 2018

DrugPatentWatch Database Preview

Drug Master Files for: dexmedetomidine

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dexmedetomidine Drug Master Files

DMF No. Status Type Submission Date Holder Subject
13810 A II 10/30/1998 FERMION OY DEXMEDETOMIDINE HYDROCHLORIDE
22681 A II 3/31/2009 ALCAMI WISCONSIN CORP DEXMEDETOMIDINE HYDROCHLORIDE USP (FP-071)
23132 A II 9/28/2009 RELIABLE BIOPHARMACEUTICAL LLC DEXMEDETOMIDINE HCI
23232 A II 10/30/2009 GLAND PHARMA LTD DEXMEDETOMIDINE HYDROCHLORIDE USP
24202 A II 12/15/2011 CHEMWERTH INC DEXMEDETOMIDINE HCL
26223 A II 7/16/2012 ASYMCHEM LABORATORIES TIANJIN CO LTD DEXMEDETOMIDINE HYDROCHLORIDE
26377 A II 9/4/2012 JIANGSU HENGRUI MEDICINE CO LTD DEXMEDETOMIDINE HYDROCHLORIDE USP, NON-STERILE, BULK DRUG SUBSTANCE
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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Fuji
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