Drug Master Files for: daptomycin

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daptomycin Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
22923	A	II	6/15/2009	OLON SPA	DAPTOMYCIN
24723	A	II	3/4/2011	ZHEJIANG HISUN PHARMACEUTICAL CO LTD	DAPTOMYCIN
26604	A	II	12/21/2012	HISUN PHARMACEUTICAL HANGZHOU CO LTD	DAPTOMYCIN
26778	A	II	1/7/2013	ZHEJIANG MEDICINE CO LTD XINCHANG PHARMACEUTICAL FACTORY	DAPTOMYCIN
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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