Drug Master Files for: DOCETAXEL

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DOCETAXEL Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
20021	A	II	12/8/2006	SCINOPHARM TAIWAN LTD	DOCETAXEL USP
20608	I	II	6/11/2007	ACCORD HEALTHCARE INC	ANHYDROUS DOCETAXEL
20722	I	II	6/20/2007	SAI PHYTOCEUTICALS PVT LTD	DOCETAXEL TRIHYDRATE
20942	A	II	10/12/2007	SCINOPHARM TAIWAN LTD	DOCETAXEL TRIHYDRATE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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