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Last Updated: July 11, 2020

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Drug Master Files for: ivabradine hydrochloride


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ivabradine hydrochloride Drug Master Files

DMF No. Status Type Submission Date Holder Subject
27979 A II 3/14/2014 ORIL INDUSTRIE IVABRADINE HYDROCHLORIDE
28658 A II 9/29/2014 BEIJING HUIKANG BOYUAN CHEMICAL TECH CO LTD IVABRADINE HYDROCHLORIDE
32074 A II 9/30/2017 ALEMBIC PHARMACEUTICALS LTD IVABRADINE HYDROCHLORIDE
32420 A II 2/7/2018 JIANGSU HENGRUI MEDICINE CO LTD IVABRADINE MONOSULFATE
33077 A II 9/21/2018 BIONPHARMA INC IVABRADINE HYDROCHLORIDE
33107 A II 10/31/2018 CADILA HEALTHCARE LTD IVABRADINE HYDROCHLORIDE
33213 A II 10/15/2018 URQUIMA SA IVABRADINE HYDROCHLORIDE (FORM IV)
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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