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Last Updated: November 4, 2024

Drug Master Files for: metolazone


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metolazone Drug Master Files

DMF No. Status Type Submission Date Holder Subject
11958 A II 5/2/1996 AMRI RENSSELAER INC METOLAZONE, USP
16001 I II 6/10/2002 XIAN LIBANG PHARMACEUTICAL CO LTD METOLAZONE USP
30310 A II 3/21/2016 CENTAUR PHARMACEUTICALS PRIVATE LTD METOLAZONE USP
32868 A II 6/28/2018 BIOPHORE INDIA PHARMACEUTICALS PVT LTD METOLAZONE USP
4655 I II 9/15/1982 EASTMAN KODAK CO METOLAZONE (ZAROXOLYN)
5748 A II 3/11/1985 SIEGFRIED EVIONNAZ SA METOLAZONE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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