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Last Updated: April 10, 2021

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Drug Master Files for: ADEFOVIR DIPIVOXIL

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ADEFOVIR DIPIVOXIL Drug Master Files

DMF No. Status Type Submission Date Holder Subject
20192 I II 3/27/2007 CIPLA LTD ADEFOVIR DIPIVOXIL
23844 A II 6/3/2010 SIGMAPHARM LABORATORIES LLC AMORPHOUS ADEFOVIR DIPIVOXIL (11.6% COPOVIDONE DISPERSION)
23993 I II 7/26/2010 SUN PHARMACEUTICAL INDUSTRIES LTD ADEFOVIR DIPIVOXIL
24151 A II 8/28/2010 ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTD ADEFOVIR DIPIVOXIL DMC (ADVANCE INTERMEDIATE)
24336 I II 10/21/2010 ALP PHARM BEIJING CO LTD ADEFOVIR DIPIVOXIL
25641 I II 12/28/2011 QILU PHARMACEUTICAL CO LTD ADEFOVIR DIPIVOXIL (NON STERILE, API)
26117 A II 5/30/2012 MYLAN LABORATORIES LTD ADEFOVIR DIPIVOXIL
>DMF No. >Status >Type >Submission Date >Holder >Subject

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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
AstraZeneca
Merck
Express Scripts
McKinsey
Johnson and Johnson

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