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Fuji

Generated: September 15, 2019

DrugPatentWatch Database Preview

Drug Master Files for: carvedilol

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carvedilol Drug Master Files

DMF No. Status Type Submission Date Holder Subject
15865 A II 2/20/2002 TEVA PHARMACEUTICAL INDUSTRIES LTD CARVEDILOL USP
16044 A II 7/8/2002 MOEHS IBERICA SL CARVEDILOL
16330 A II 1/29/2003 DR REDDYS LABORATORIES LTD CARVEDILOL FORM-2
16530 I II 4/8/2003 ZENTIVA AS CARVEDILOL
17060 A II 12/18/2003 ZAKLADY FARMACEUTYCZNE POLPHARMA SA CARVEDILOL
17187 A II 2/25/2004 CIPLA LTD CARVEDILOL USP
17405 I II 5/17/2004 ZACH SYSTEM SPA CARVEDILOL
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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Serving hundreds of leading biopharmaceutical companies globally:

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