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Last Updated: November 22, 2024

Drug Master Files for: carbidopa


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carbidopa Drug Master Files

DMF No. Status Type Submission Date Holder Subject
11246 I II 12/8/1994 KNOLL AG CARBIDOPA
17846 A II 11/20/2004 DIVIS LABORATORIES LTD CARBIDOPA USP
18245 I II 4/5/2005 SMRUTHI ORGANICS LTD CARBIDOPA USP
19899 A II 10/16/2006 ZHEJIANG CHIRAL MEDICINE CHEMICALS CO LTD CARBIDOPA
22424 A II 12/10/2008 ZHEJIANG WILD WIND PHARMACEUTICAL CO LTD CARBIDOPA (NON-STERILE, BULK FORM)
25563 A II 12/7/2011 GLOCHEM INDUSTRIES PRIVATE LTD CARBIDOPA
26416 A II 9/14/2012 FERMION OY CARBIDOPA
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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