Drug Master Files for: ERLOTINIB HYDROCHLORIDE

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ERLOTINIB HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
21786	A	II	7/11/2008	NATCO PHARMA LTD	ERLOTINIB HYDROCHLORIDE
23136	I	II	7/27/2009	TAI HENG INDUSTRY CO LTD	ERLOTINIB HYDROCHLORIDE
23183	A	II	10/16/2009	TEVA PHARMACEUTICAL INDUSTRIES LTD	ERLOTINIB HCL
23345	I	II	11/30/2009	ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD	ERLOTINIB HYDROCHLORIDE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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