Drug Master Files for: DRONEDARONE HYDROCHLORIDE

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DRONEDARONE HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
18409	A	II	6/8/2005	SANOFI CHIMIE	DRONEDARONE HYDROCHLORIDE
25669	A	II	2/16/2012	UNIMARK REMEDIES LTD	DRONEDARONE HYDROCHLORIDE
26023	A	II	4/25/2012	MYLAN LABORATORIES LTD	DRONEDARONE HYDROCHLORIDE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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