Drug Master Files for: PYRIDOSTIGMINE BROMIDE

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PYRIDOSTIGMINE BROMIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10593	A	II	11/30/1993	PATHEON AUSTRIA GMBH AND CO KG	PYRIDOSTIGMINE BROMIDE
10877	I	II	4/11/1994	HELSINN ADVANCED SYNTHESIS SA	PYRIDOSTIGMINE BROMIDE
11972	I	II	5/10/1996	ROCHE PRODUCTS LTD	PYRIDOSTIGMINE BROMIDE TABLETS USP 30MG
15665	A	II	10/16/2001	POLYCARBON INDUSTRIES INC DBA PCI SYNTHESIS	PYRIDOSTIGMINE BROMIDE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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