Last Updated: November 8, 2026

Drug Master Files for: ciclopirox

ciclopirox Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11389	A	II	3/17/1995	OLON SPA	CICLOPIROX OLAMINE
14627	A	II	12/17/1999	SANOFI AVENTIS DEUTSCHLAND GMBH	CICLOPIROX
14633	I	II	12/17/1999	SANOFI AVENTIS DEUTSCHLAND GMBH	CICLOPIROX OLAMINE
16352	A	II	1/2/2003	ERREGIERRE SPA	CICLOPIROX OLAMINE USP-PH.EUR.
16353	A	II	12/30/2002	ERREGIERRE SPA	CICLOPIROX USP-EP
17007	A	II	12/1/2003	PCAS	CICLOPIROX
17156	A	II	2/16/2004	OLON SPA	CICLOPIROX
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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