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Generated: December 17, 2018

DrugPatentWatch Database Preview

Drug Master Files for: omega-3-acid ethyl esters type a

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omega-3-acid ethyl esters type a Drug Master Files

DMF No. Status Type Submission Date Holder Subject
14685 A II 1/26/2000 CATALENT PHARMA SOLUTIONS LLC LOVAZA 1 G SOFT GELATIN CAPSULES(OMEGA-3-ACID ETHYL ESTERS, 1 GRAM)
22106 A II 10/17/2008 CRODA EUROPE LTD OMEGA-3-ACID ETHYL ESTERS
22284 I II 11/3/2008 OLON SPA OMEGA-3-ACID ETHYL ESTERS
22285 A II 10/17/2008 HUATAI BIOPHARM INC OMEGA-3-ACID ETHYL ESTERS USP
23905 I II 7/12/2010 KD PHARMA BEXBACH GMBH OMEGA-3-ACIDS ETHYL ESTER
25342 A II 9/7/2011 CHEMPORT INC OMEGA-3-ACID ETHYL ESTERS
26056 A II 8/31/2012 PRONOVA BIOPHARMA NORGE AS OMEGA-3-ACID ETHYL ESTERS
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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