Drug Master Files for: bethanechol chloride

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bethanechol chloride Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
15213	A	II	12/20/2000	CORDEN PHARMA BERGAMO SPA	BETHANECHOL CHLORIDE
15737	A	II	11/21/2001	SIEGFRIED EVIONNAZ SA	BETHANECHOL CHLORIDE
15866	A	II	2/18/2002	SERATEC SAS	BETHANECHOL CHLORIDE USP
16119	A	II	8/27/2002	WOCKHARDT LTD	BETHANECHOL CHLORIDE USP
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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