Drug Master Files for: OXYBUTYNIN CHLORIDE

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OXYBUTYNIN CHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11478	I	II	4/27/1995	SELOC AG	OXYBUTYNIN BASE
11947	A	II	4/26/1996	SIEGFRIED EVIONNAZ SA	OXYBUTYNIN BASE
12309	A	II	1/9/1997	CORDEN PHARMA CHENOVE	OXYBUTYNIN HYDROCHLORIDE
12840	I	II	2/2/1998	SANOFI AVENTIS SPA	OXYBUTYNIN CHLORIDE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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