Drug Master Files for: IVABRADINE HYDROCHLORIDE

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IVABRADINE HYDROCHLORIDE Drug Master Files

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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
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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