Drug Master Files for: NILOTINIB HYDROCHLORIDE

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NILOTINIB HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
25338	I	II	9/28/2011	ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD	NILOTINIB HYDROCHLORIDE MONOHYDRATE (FORM B) (VERSION NO.: 1)
25412	I	II	10/19/2011	ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD	NILOTINIB HYDROCHLORIDE MONOHYDRATE (VERSION NO.: 1)
26497	I	II	9/28/2012	SICHUAN XIELI PHARMACEUTICAL CO LTD	NILOTINIB
28102	A	II	7/15/2014	TEVA PHARMACEUTICAL INDUSTRIES LTD	NILOTINIB HYDROCHLORIDE
30088	A	II	12/31/2015	DR REDDYS LABORATORIES LTD	NILOTINIB HYDROCHLORIDE
30098	A	II	12/9/2015	HETERO LABS LTD	NILOTINIB HYDROCHLORIDE DIHYDRATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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