Drug Master Files for: SPIRONOLACTONE

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SPIRONOLACTONE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
14077	A	II	3/29/1999	GEDEON RICHTER PLC	SPIRONOLACTONE USP
17264	A	II	3/26/2004	SANOFI CHIMIE	SPIRONOLACTONE
18238	A	II	3/31/2005	TIANJIN TIANYAO PHARMACEUTICALS CO LTD	SPIRONOLACTONE USP
18546	I	II	7/20/2005	OLON SPA	SPIRONOLACTONE
19859	I	II	10/12/2006	ZHEJIANG XINHUA PHARMACEUTICAL CO LTD	SPIRONOLACTONE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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