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Last Updated: November 24, 2024

Drug Master Files for: valacyclovir hydrochloride


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valacyclovir hydrochloride Drug Master Files

DMF No. Status Type Submission Date Holder Subject
16300 A II 12/11/2002 SUN PHARMACEUTICAL INDUSTRIES LTD VALACYCLOVIR HYDROCHLORIDE USP (HYDROUS)
17223 A II 3/10/2003 CIPLA LTD VALACYCLOVIR HYDROCHLORIDE DIHYDRATE USP
17794 A II 10/25/2004 TEVA PHARMACEUTICAL INDUSTRIES LTD VALACYCLOVIR HYDROCHLORIDE
17943 A II 12/29/2004 MYLAN LABORATORIES LTD VALACYCLOVIR HYDROCHLORIDE USP
18940 I II 10/25/2005 OLON SPA VALACYCLOVIR HYDROCHLORIDE MONOHYDRATE
20278 I II 2/9/2007 EOS ECZACIBASI OZGUN KIMYASAL URUNLER SANAYI VE TICARET AS VALACYCLOVIR HCI MONOHYDRATE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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