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Last Updated: March 28, 2024

Drug Master Files for: RABEPRAZOLE SODIUM


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RABEPRAZOLE SODIUM Drug Master Files

DMF No. Status Type Submission Date Holder Subject
16747 A II 8/4/2003 DR REDDYS LABORATORIES LTD RABEPRAZOLE SODIUM HYDRATE (FORM Y) USP
16764 I II 8/18/2003 CIPLA LTD RABEPRAZOLE SODIUM
18226 I II 3/31/2005 CADILA HEALTHCARE LTD RABEPRAZOLE SODIUM
19186 A II 1/31/2006 AUROBINDO PHARMA LTD RABEPRAZOLE SODIUM
19903 A II 10/25/2006 LUPIN LTD RABEPRAZOLE SODIUM
20818 I II 8/29/2007 AMINO CHEMICALS LTD RABEPRAZOLE SODIUM MONOHYDRATE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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