Drug Master Files for: PACLITAXEL

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PACLITAXEL Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10504	I	II	9/29/1993	NAPRO BIOTHERAPEUTICS INC	PACLITAXEL DRUG SUBSTANCE
11248	I	II	9/5/1995	HAUSER CHEMICAL RESEARCH INC	PACLITAXEL
11841	I	II	1/29/1996	NAPRO BIOTHERAPEUTICS INC	PACLITAXEL DRUG SUBSTANCE
11909	A	II	3/29/1996	YUNNAN HANDE BIO-TECH CO LTD	PACLITAXEL DRUG SUBSTANCE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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