Drug Master Files for: TROSPIUM CHLORIDE

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TROSPIUM CHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
14967	I	II	7/20/2000	BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG	TROSPIUM CHLORIDE
18544	A	II	7/29/2005	HELSINN ADVANCED SYNTHESIS SA	TROSPIUM CHLORIDE
21171	I	II	10/10/2007	INTERPHARMA PRAHA AS	Trospium 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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