Drug Master Files for: IMATINIB MESYLATE

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IMATINIB MESYLATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
19499	A	II	6/6/2006	SUN PHARMACEUTICAL INDUSTRIES LTD	IMATINIB MESYLATE
20410	A	II	4/5/2007	NATCO PHARMA LTD	IMATINIB MESYLATE (ALPHA 2-FORM)
21006	A	II	11/2/2007	TEVA PHARMACEUTICAL INDUSTRIES LTD	IMATINIB MESYLATE
23139	I	II	10/1/2009	MYLAN LABORATORIES LTD	IMATINIB MESYLATE
23343	A	II	11/30/2009	ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD	IMATINIB MESYLATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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