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Generated: September 22, 2018

DrugPatentWatch Database Preview

Drug Master Files for: bismuth subcitrate potassium; metronidazole; tetracycline

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bismuth subcitrate potassium; metronidazole; tetracycline Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10655 I II 12/6/1993 PCAS BISMUTH CITRATE
10665 I II 12/6/1993 PCAS MANUFACTURING FACILITY FOR BISMUTH CITRATE AT LA VOULTE SUR RHONE
11889 I II 3/11/1996 OMICRON QUIMICA SA BISMUTH SUBSALICYLATE
12723 I II 10/29/1997 OMICRON QUIMICA SA BISMUTH SUBCITRATE
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Cantor Fitzgerald
Chubb
UBS
Teva
Daiichi Sankyo
Cipla
Colorcon
Medtronic

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