Drug Master Files for: molindone hydrochloride

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molindone hydrochloride Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10261	I	II	5/26/1993	BIOREX RESEARCH DEVELOPMENT CO	MOLINDONE HYDROCHLORIDE
19448	A	II	5/18/2006	PAR A TECHNOLOGIES PRIVATE LTD	MOLINDONE HYDROCHLORIDE
20775	A	II	8/16/2007	APICORE US LLC	MOLINDONE HYDROCHLORIDE USP
7992	I	II	3/21/1989	CILAG AG	MOLINDONE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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