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Generated: November 18, 2018

DrugPatentWatch Database Preview

Drug Master Files for: Pliva

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Pliva Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10645 I II 1/3/1993 PLIVA CROATIA LTD MESALAZINE
13349 I II 9/1/1998 PLIVA OXYTETRACYCLINE HYDROCHLORIDE
13350 I II 9/1/1998 PLIVA CROATIA LTD OXYTETRACYCLINE
13919 I II 12/29/1998 PLIVA DD PEMOLINE
14079 I II 4/15/1999 PLIVA DD MANUFACTURING SITE, PERSONNEL, AND OPERATING PROCEDURES FOR AZITHROMYCIN DIHYDRATE
16280 I II 12/2/2002 PLIVA-LACHEMA AS CARBOPLATIN
16326 I II 12/19/2002 PLIVA LACHEMA AS DACARBAZINE
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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Medtronic
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Cerilliant
Johnson and Johnson
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McKesson

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