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Last Updated: August 9, 2020

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Drug Master Files for: RITONAVIR

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RITONAVIR Drug Master Files

DMF No. Status Type Submission Date Holder Subject
11666 I II 9/11/1995 FINORGA SAS RITONAVIR
11672 A II 9/22/1995 PRIME EUROPEAN THERAPEUTICALS SPA (EUTICALS SPA) A-84538.0 (RITONAVIR)
11677 I II 9/25/1995 AJINOMOTO CO INC A-84538.0 (RITONAVIR)
12747 I II 11/17/1997 CATALENT PHARMA SOLUTIONS LLC RITONAVIR, 100MG AND 200MG SOFT-GELATIN CAPSULE
14807 I II 3/29/2000 CATALENT PHARMA SOLUTIONS LLC LOPINAVIR/RITONAVIR 133.3/33.3MG SOFT GELATIN CAPSULES
19037 A II 12/9/2005 AUROBINDO PHARMA LTD RITONAVIR USP
19800 A II 9/26/2006 MYLAN LABORATORIES LTD RITONAVIR USP (FORM-II)
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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