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Last Updated: July 23, 2021

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Drug Master Files for: ENTACAPONE


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ENTACAPONE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
12444 A II 3/26/1997 FERMION OY ENTACAPONE
19092 A II 1/6/2006 SUVEN LIFE SCIENCES LTD ENTACAPONE
19385 A II 3/1/2006 WOCKHARDT LTD ENTACAPONE USP
20326 A II 2/28/2007 SUN PHARMACEUTICAL INDUSTRIES LTD ENTACAPONE
21526 A II 4/11/2008 NEULAND LABORATORIES LTD ENTACAPONE USP (FORM-A)
22133 I II 11/21/2008 USV LTD ENTACAPONE
22538 A II 2/17/2009 DIPHARMA FRANCIS SRL ENTACAPONE
>DMF No. >Status >Type >Submission Date >Holder >Subject

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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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