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Generated: May 23, 2019

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Drug Master Files for: dimethyl

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dimethyl Drug Master Files

DMF No. Status Type Submission Date Holder Subject
1067 I II 6/29/1967 ARAPAHOE CHEMICALS INC DIV SYNTEX LABORATORIES INC DIMETHYL SULFOXIDE
10756 I II 2/28/1994 RAYLO CHEMICALS INTERMEDIATE FOR ACA-147, 4-(2,2-DIMETHYLPROPYL)-N-HEXYLBENZENEMETHANAMINE HYDROCHLORIDE
11727 A II 10/31/1995 KOEI CHEMICAL CO LTD BOC-PIPERAZINE (S)-3-[[(1,1-DIMETHYLETHYL) AMINO] CARBONYL] -1- PIPERAZINECARBOXYLIC ACID 1,1-DIMETHYLETHYL ESTER
12028 I II 7/8/1996 MICROBIOPHARM JAPAN CO LTD (1S,3R)-1,3-BIS(TERT-BUTYLDIMETHYLSILYLOXY) ANDROST-5-EN-17-ONE (SI-HDEA)
1214 I II 8/1/1968 TROPONWERKE GMBH CO KG PHENTERMINE (C.A. NAME,-DIMETHYLPHENETHYLAMINE)
12706 A II 10/20/1997 GAYLORD CHEMICAL CO LLC DIMETHYL SULFOXIDE (DMSO), USP GRADE
14335 A II 8/6/1999 KATWIJK CHEMIE BV 1,2-DIMETHYL-3-HYDROXY-PYRIDONE-4(DEFERIPONE)
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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