Drug Master Files for: ARTESUNATE

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ARTESUNATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
20188	A	II	4/15/2008	CIPLA LTD	ARTESUNATE
22218	I	II	1/22/2009	IPCA LABORATORIES LTD	ARTESUNATE
24028	A	II	8/5/2010	SOLARA A PHARMA SCIENCES LTD	ARTESUNATE
27825	I	II	12/16/2013	HUVEPHARMA ITALIA SRL	ARTESUNATE
31686	A	II	4/7/2017	HUVEPHARMA ITALIA SRL	ARTESUNATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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