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Generated: September 18, 2018

DrugPatentWatch Database Preview

Drug Master Files for: Qilu Tianhe

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Qilu Tianhe Drug Master Files

DMF No. Status Type Submission Date Holder Subject
18883 I II 10/18/2005 QILU TIANHE PHARMACEUTICAL CO LTD TAZOBACTAM ACID (INTERMEDIATE, NON-STERILE BULK)
20428 A II 4/5/2007 QILU TIANHE PHARMACEUTICAL CO LTD TAZOBACTAM ACID (PROCESS I, NON-STERILE BULK)
20432 A II 4/9/2007 QILU TIANHE PHARMACEUTICAL CO LTD STERILE PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM (8:1)
20615 A II 6/15/2007 QILU TIANHE PHARMACEUTICAL CO LTD HYDROXYUREA USP (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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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