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Last Updated: December 9, 2019

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Drug Master Files for: fenoldopam

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fenoldopam Drug Master Files

DMF No. Status Type Submission Date Holder Subject
16145 A II 9/24/2002 SAGE CHEMICALS INC FENOLDOPAM MESYLATE USP
16582 A II 5/12/2003 CHEMWERTH INC FENOLDOPAM MESYLATE (NON-STERILE BULK DRUG SUBSTANCE)
17248 A II 3/22/2004 RELIABLE BIOPHARMACEUTICAL LLC FENOLDOPAM MESYLATE, USP
19636 I II 6/14/2006 EPOCH BIOSCIENCES SHENZHEN CO LTD FENOLDOPAM MESYLATE BULK A API
19768 I II 9/2/2006 ISOCHEM FENOLDOPAM MESYLATE USP
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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Serving leading biopharmaceutical companies globally:

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