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Generated: October 17, 2018

DrugPatentWatch Database Preview

Drug Master Files for: Perrigo

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Perrigo Drug Master Files

DMF No. Status Type Submission Date Holder Subject
15692 A II 10/31/2001 PERRIGO API LTD FLUMAZENIL
16784 I II 8/20/2003 PERRIGO API LTD TERBINAFINE HYDROCHLORIDE
17027 I II 11/30/2003 PERRIGO API LTD ZONISAMIDE
17523 I II 7/8/2004 PERRIGO API LTD DONEPEZIL HYDROCHLORIDE (DILUTED) 25% AMORPHOUS
18084 I II 2/15/2005 PERRIGO API LTD PENTOXYFYLLINE
18413 A II 6/9/2005 ZIBO XINHUA PERRIGO PHARMACEUTICAL CO LTD IBUPROFEN USP DRUG SUBSTANCE
19808 A II 9/27/2006 PERRIGO API LTD ANASTROZOLE
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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