Last Updated: November 8, 2026

Drug Master Files for: MICONAZOLE

MICONAZOLE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10518	A	II	9/30/1993	OLON SPA	MICONAZOLE NITRATE
10579	I	II	11/16/1993	KV PHARMACEUTICAL CO	MICONAZOLE VAGINAL CREAM
10912	I	II	5/20/1994	JANSSEN PHARMACEUTICA NV	MICONAZOLE DRUG SUBSTANCE
10913	A	II	5/20/1994	JANSSEN PHARMACEUTICA NV	MICONAZOLE NITRATE DRUG SUBSTANCE
10970	I	II	6/28/1994	GUANGDONG PHARMACEUTICAL FACTORY	MICONAZOLE NITRATE
11562	A	II	6/20/1995	CORDEN PHARMA BERGAMO SPA	MICONAZOLE NITRATE
12455	I	II	4/7/1997	GUFIC BIOSCIENCES LTD	MICONAZOLE NITRATE USP
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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