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Last Updated: November 22, 2024

Drug Master Files for: CHLORPHENIRAMINE MALEATE


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CHLORPHENIRAMINE MALEATE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
17311 A II 4/1/2004 SPECGX LLC CHLORPHENIRAMINE POLISTIREX
21003 I II 10/31/2007 GRANULES INDIA LTD Chlorpheniramine Maleate USP
21355 A II 2/5/2008 KESHAVA ORGANICS PVT LTD DEXCHLORPHENIRAMINE MALEATE
21356 A II 2/5/2008 KESHAVA ORGANICS PVT LTD CHLORPHENIRAMINE MALEATE
21719 I II 5/19/2008 HARIKA DRUGS PRIVATE LTD CHLORPHENIRAMINE TANNATE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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