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Last Updated: March 28, 2024

Drug Master Files for: lopinavir


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lopinavir Drug Master Files

DMF No. Status Type Submission Date Holder Subject
14807 I II 3/29/2000 CATALENT PHARMA SOLUTIONS LLC LOPINAVIR/RITONAVIR 133.3/33.3MG SOFT GELATIN CAPSULES
19600 I II 7/17/2006 MYLAN LABORATORIES LTD LOPINAVIR (LVR)
19852 A II 10/10/2006 HETERO LABS LTD LOPINAVIR USP
19862 A II 10/9/2006 AUROBINDO PHARMA LTD LOPINAVIR (NON STERILE DRUG SUBSTANCE)
20363 A II 5/30/2007 MYLAN LABORATORIES LTD LOPINAVIR USP (LOP)
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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