Drug Master Files for: PROPAFENONE HYDROCHLORIDE

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PROPAFENONE HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10641	A	II	12/16/1993	PHARMAZELL GMBH	PROPAFENONE HYDROCHLORIDE
11426	A	II	4/3/1995	PROCOS SPA	PROPAFENONE HYDROCHLORIDE
11568	A	II	6/29/1995	FERMION OY	PROPAFENONE HCL
12691	I	II	10/9/1997	SIEGFRIED CHEMIE AG LTD	PROPAFENONE HYDROCHLORIDE
13010	A	II	6/1/1998	ERREGIERRE SPA	PROPAFENONE HYDROCHLORIDE USP-EP
14985	A	II	8/29/2000	CAMBREX PROFARMACO MILANO SRL	PROPAFENONE HYDROCHLORIDE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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