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Last Updated: February 27, 2021

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Drug Master Files for: rilpivirine

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rilpivirine Drug Master Files

DMF No. Status Type Submission Date Holder Subject
23824 A II 7/19/2010 JANSSEN PHARMACEUTICA NV RILPIVIRINE HYDROCHLORIDE (R314585) DRUG SUBSTANCE
26305 A II 8/3/2012 SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTD RILPIVIRINE HYDROCHLORIDE
27253 A II 7/24/2013 MYLAN LABORATORIES LTD RILPIVIRINE HYDROCHLORIDE
29301 A II 4/16/2015 HETERO DRUGS LTD RILPIVIRINE HYDROCHLORIDE
29841 A II 12/8/2015 LAURUS LABS LTD RILPIVIRINE HYDROCHLORIDE
30423 A II 3/31/2016 MSN PHARMACHEM PRIVATE LTD RILPIVIRINE HYDROCHLORIDE [ROUTE CODE RC]
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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