Drug Master Files for: OXALIPLATIN

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OXALIPLATIN Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10039	I	II	1/15/1993	TANAKA KIKINZOKU KOGYO	MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF OXALIPLATIN IN KANAGAWA, JAPAN.
10040	A	II	1/15/1993	TANAKA KIKINZOKU KOGYO	OXALIPLATIN
16952	A	II	11/11/2003	JOHNSON MATTHEY INC	OXALIPLATIN
19559	A	II	6/28/2006	TEVA PHARMACEUTICAL INDUSTRIES LTD	OXALIPLATIN
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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