Drug Master Files for: TERCONAZOLE

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TERCONAZOLE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
12887	A	II	2/19/1998	ALBEMARLE CORP	TERCONAZOLE
14622	A	II	12/10/1999	QUIMICA SINTETICA SA	TERCONAZOLE
15680	I	II	10/22/2001	APOTECNIA SA	TERCONAZOLE
20735	A	II	7/30/2007	DERIVADOS QUIMICOS SAU	TERCONAZOLE
24663	A	II	4/14/2011	TARO PHARMACEUTICAL INDUSTRIES LTD	TERCONAZOLE USP (MICRONIZED)
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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