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Fish and Richardson
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Generated: May 23, 2019

DrugPatentWatch Database Preview

Drug Master Files for: colchicine

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colchicine Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10088 A II 2/10/1993 INDENA SPA COLCHICINE USP
11771 I II 12/12/1995 SM ORGANICS PRIVATE LTD COLCHICINE
17003 I II 12/1/2003 ALCHEM INTERNATIONAL LTD COLCHICINE USP
18032 I II 1/25/2005 ALKALOIDS CORP COLCHICINE USP
20149 A II 1/12/2007 SANMAR SPECIALITY CHEMICALS LTD COLCHICINE USP NON-STERILE BULK DRUG SUBSTANCE
2113 I II 6/13/1973 LILLY RESEARCH LABORATORIES DIV ELI LILLY AND CO #560 COLCHICINE
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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