Drug Master Files for: risperidone

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risperidone Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11438	A	II	4/11/1995	JANSSEN PHARMACEUTICA NV	RISPERIDONE (R064766) DRUG SUBSTANCE
15604	A	II	8/29/2001	TEVA PHARMACEUTICAL INDUSTRIES LTD	RISPERIDONE USP
15682	A	II	10/23/2001	INKE SA	RISPERIDONE
16023	I	II	6/20/2002	DR REDDYS LABORATORIES LTD	RISPERIDONE EP
16516	I	II	4/1/2003	MEDICHEM SA	RISPERIDONE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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