Drug Master Files for: butoconazole nitrate

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butoconazole nitrate Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
13106	I	II	7/6/1998	QUIMICA SINTETICA SA	BUTOCONAZOLE NITRATE
15929	I	II	4/8/2002	GEDEON RICHTER PLC	BUTOCONAZOLE NITRATE
17944	I	II	12/3/2004	HONEYWELL IROPHARM PLC	BUTOCONAZOLE
18981	A	II	11/29/2005	DERIVADOS QUIMICOS SAU	BUTOCONAZOLE NITRATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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