Drug Master Files for: FLUCONAZOLE

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FLUCONAZOLE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11524	I	II	5/24/1995	CIPLA LTD	FLUCONAZOLE USP
14419	I	II	9/23/1999	CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD	FLUCONAZOLE
14714	A	II	12/15/1999	INKE SA	FLUCONAZOLE
14863	I	II	5/2/2000	WOCKHARDT LTD	FLUCONAZOLE
15045	A	II	8/11/2000	MYLAN LABORATORIES LTD	FLUCONAZOLE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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