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Last Updated: February 16, 2020

DrugPatentWatch Database Preview

Drug Master Files for: LAMIVUDINE; ZIDOVUDINE


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LAMIVUDINE; ZIDOVUDINE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
17535 A II 7/19/2004 CIPLA LTD LAMIVUDINE USP
17750 A II 10/8/2004 MYLAN LABORATORIES LTD LAMIVUDINE USP
17900 A II 12/3/2004 AUROBINDO PHARMA LTD LAMIVUDINE USP
18252 A II 4/7/2005 HETERO LABS LTD LAMIVUDINE USP (PROCESS I)
18713 A II 8/18/2005 AUROBINDO PHARMA LTD LAMIVUDINE USP
20067 I II 12/14/2006 SUN PHARMACEUTICAL INDUSTRIES LTD LAMIVUDINE USP
20468 I II 3/30/2007 ANHUI BIOCHEM PHARM CO LTD LAMIVUDINE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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