Drug Master Files for: ITRACONAZOLE

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ITRACONAZOLE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10725	A	II	2/18/1994	JANSSEN PHARMACEUTICA NV	ITRACONAZOLE DRUG SUBSTANCE
12697	A	II	10/16/1997	ALBEMARLE CORP	ITRACONAZOLE USP & PH EUR
13012	A	II	5/28/1998	QUIMICA SINTETICA SA	ITRACONAZOLE
14507	I	II	11/9/1999	QUIMICA FINA FARMEX SA DE CV	ITRACONAZOLE
15445	A	II	5/15/2001	NEULAND LABORATORIES LTD	ITRACONAZOLE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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