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Generated: November 18, 2018

DrugPatentWatch Database Preview

Drug Master Files for: donepezil

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donepezil Drug Master Files

DMF No. Status Type Submission Date Holder Subject
15694 A II 10/29/2001 FINETECH PHARMACEUTICAL LTD DONEPEZIL HYDROCHLORIDE
16674 I II 6/30/2003 SUN PHARMACEUTICAL INDUSTRIES LTD DONEPEZIL HYDROCHLORIDE (MONOHYDRATE) USP
17523 I II 7/8/2004 PERRIGO API LTD DONEPEZIL HYDROCHLORIDE (DILUTED) 25% AMORPHOUS
17779 A II 10/26/2004 DR REDDYS LABORATORIES LTD DONEPEZIL HYDROCHLORIDE MONOHYDRATE (FORM-1) USP
18422 A II 6/9/2005 CIPLA LTD DONEPEZIL HYDROCHLORIDE FORM-I
19048 A II 12/16/2005 JUBILANT GENERICS LTD DONEPEZIL HYDROCHLORIDE USP(ANHYDROUS FORM-1)
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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