Drug Master Files for: amiodarone hydrochloride

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amiodarone hydrochloride Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
14171	I	II	5/28/1999	SHANGHAI SHENLONG PHARMACEUTICAL CO LTD	AMIODARONE HYDROCHLORIDE
15794	A	II	12/27/2001	TARO PHARMACEUTICAL INDUSTRIES LTD	AMIODARONE HCL USP
16787	A	II	8/27/2003	GLENMARK PHARMACEUTICALS LTD	AMIODARONE HYDROCHLORIDE USP
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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