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Generated: April 18, 2019

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Drug Master Files for: talc

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talc Drug Master Files

DMF No. Status Type Submission Date Holder Subject
14009 I III 2/4/1999 AMPACET CORP 110733 WHITE TALC POLYETHYLENE MASTERBATCH
14598 I III 11/18/1999 AMPACET CORP 10799-A TALC POLYETHYLENE MASTERBATCH
1829 I II 11/22/1971 CHEMICAL CORP AMERICA INC CADOX BCP - SILICA - TALC
26172 A II 6/7/2012 CHONGQING PHARSCIN PHARMACEUTICAL CO LTD HYDROTALCITE NON STERILE, DRUG SUBSTANCE
28604 A III 9/8/2014 POLYPACIFIC PTY LTD PROPAK 7021 40% TALC FILLED POLYPROPYLENE HOMOPOLYMER COMPOUND
33391 A IV 12/8/2018 NEELKANTH MINECHEM TALCUM POWDER IP/BP/USP
5393 I II 5/31/1984 A INC A QAE-CELLULOSE-1 ION EXCHG.MEDIA(STAFFORD SPRINGS & TALCOTTVILLE,CT
DMF No. Status Type Submission Date Holder Subject

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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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