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Generated: November 20, 2018

DrugPatentWatch Database Preview

Drug Master Files for: carboplatin

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carboplatin Drug Master Files

DMF No. Status Type Submission Date Holder Subject
12369 I II 2/21/1997 DEGUSSA AG WERK RADEBEUL CARBOPLATIN, USP
15147 A II 11/17/2000 HERAEUS DEUTSCHLAND GMBH AND CO KG CARBOPLATIN USP
15938 A II 4/18/2002 STREM CHEMICALS INC CARBOPLATIN (USP)
16280 I II 12/2/2002 PLIVA-LACHEMA AS CARBOPLATIN
16664 A II 6/20/2003 SUN PHARMACEUTICAL INDUSTRIES LTD CARBOPLATIN USP
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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