Drug Master Files for: CAPECITABINE

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CAPECITABINE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
21620	A	II	8/19/2009	CIPLA LTD	CAPECITABINE USP
22014	I	II	8/28/2008	JIANGSU ZW PHARMACEUTICALS CO LTD	CAPECITABINE
22140	A	II	10/27/2008	HETERO LABS LTD	CAPECITABINE, USP
22157	A	II	10/27/2008	DIVI'S LABOTATORIES LTD	CAPECITABINE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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