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Last Updated: January 25, 2020

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Drug Master Files for: ribavirin

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ribavirin Drug Master Files

DMF No. Status Type Submission Date Holder Subject
12156 A II 9/30/1996 SIEGFRIED EVIONNAZ SA RIBAVIRIN
12766 I II 11/27/1997 YAMASA CORP RIBAVIRIN
15503 A II 6/21/2001 STAR LAKE BIOSCIENCE CO INC RIBAVIRIN, USP
15611 A II 8/31/2001 YUHAN CHEMICAL INC RIBAVIRIN USP, 1H-1,2,4-TRIAZOLE-3-CARBOXAMIDE, 1-BETA-D-RIBOFURANOSYL
15655 I II 6/22/2001 XINXIANG PHARMACEUTICAL CO LTD RIBAVIRIN NON-STERILE BULK FORM
15700 A II 10/30/2001 PRIME EUROPEAN THERAPEUTICALS SPA (EUTICALS SPA) RIBAVIRIN USP-EP
15756 A II 10/1/2001 BIDACHEM SPA RIBAVIRIN
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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