Drug Master Files for: ARIPIPRAZOLE LAUROXIL

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ARIPIPRAZOLE LAUROXIL Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
15651	I	II	10/5/2001	BRISTOL MYERS SQUIBB CO	ARIPIPRAZOLE TABLETS
18471	I	II	6/30/2005	DR REDDYS LABORATORIES LTD	ARIPIPRAZOLE
18706	A	II	8/15/2005	ERREGIERRE SPA	ARIPIPRAZOLE USP-EP
18774	A	II	9/13/2005	CAMBREX CHARLES CITY INC	ARIPIPRAZOLE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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