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Generated: December 18, 2018

DrugPatentWatch Database Preview

Drug Master Files for: DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

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DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
1095 I II 11/2/1967 SF DURST AND CO INC DEXAMETHASONE
1142 I II 2/9/1968 DBI INC DEXAMETHASONE ACETATE
11587 I II 7/17/1995 HOECHST MARION ROUSSEL SA DEXAMETHASONE ACETATE USP MONOHYDRATE
1343 I II 3/14/1969 ORGANON INC DEXAMETHASONE 21-TERTIARY BUTYLACETATE
17141 A II 2/4/2004 TIANJIN TIANYAO PHARMACEUTICALS CO LTD DEXAMETHASONE, USP
1748 A II 6/21/1971 SANOFI CHIMIE DEXAMETHASONE
2205 I II 12/31/1973 ANTIBIOTICOS SPA DEXAMETHASONE, NON-STERILE (BULK)
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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