Drug Master Files for: ketoconazole

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ketoconazole Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10037	A	II	1/15/1993	JANSSEN PHARMACEUTICA NV	KETOCONAZOLE DRUG SUBSTANCE
10038	I	II	1/15/1993	JANSSEN RESEARCH FDN	INTERMEDIATES OF KETOCONAZOLE
11579	A	II	7/13/1995	ESTEVE QUIMICA SA	KETOCONAZOLE
12023	A	II	6/25/1996	QUIMICA SINTETICA SA	KETOCONAZOLE
12171	I	II	10/11/1996	ALBEMARLE CORP	KETOCONAZOLE
12794	I	II	12/9/1997	QUIMICA FINA FARMEX SA DE CV	KETOCONAZOLE
14794	A	II	1/19/2001	DERIVADOS QUIMICOS SAU	KETOCONAZOLE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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