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Last Updated: July 29, 2021

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Drug Master Files for: ACYCLOVIR


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ACYCLOVIR Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10044 A II 1/12/1993 RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA ACYCLOVIR
10124 I II 3/2/1993 OMNICHEM SA ACYCLOVIR
10685 A II 1/12/1994 OLON SPA ACYCLOVIR
10710 I II 2/7/1994 CIPLA LTD ACYCLOVIR
10830 A II 3/24/1994 YUNG ZIP CHEMICAL IND CO LTD ACYCLOVIR
10945 A II 6/9/1994 EXCELLA GMBH AND CO KG ACYCLOVIR SODIUM
11352 I II 2/20/1995 LEK LJUBLJANA PHARMACEUTICAL AND CHEMICAL CO ACYCLOVIR A SUBSTANCE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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