Drug Master Files for: NAFTIFINE HYDROCHLORIDE

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NAFTIFINE HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
14711	A	II	2/15/2000	ERREGIERRE SPA	NAFTIFINE HYDROCHLORIDE USP
16772	A	II	8/19/2003	NOVARTIS PHARMA AG	NAFTIFINE HYDROCHLORIDE
18147	A	II	3/4/2005	OLON SPA	NAFTIFINE HYDROCHLORIDE
23456	A	II	8/3/2010	SHANGHAI ZIYUAN PHARMACEUTICAL CO LTD	NAFTIFINE HYDROCHLORIDE
24619	A	II	6/27/2012	TARO PHARMACEUTICAL INDUSTRIES LTD	NAFTIFINE HYDROCHLORIDE USP
28735	A	II	8/10/2014	CHONGQING HUAPONT PHARMACEUTICAL CO LTD	NAFTIFINE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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