Drug Master Files for: ARMODAFINIL

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ARMODAFINIL Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
18107	A	II	2/21/2005	SIGMA ALDRICH IRELAND LTD	ARMODAFINIL DRUG SUBSTANCE
18109	I	II	2/18/2005	NOVASEP PROCESS SAS	ARMODAFINIL
19685	A	II	8/15/2006	CEPHALON INC	ARMODAFINIL DRUG SUBSTANCE
21200	A	II	12/19/2007	MYLAN LABORATORIES LTD	ARMODAFINIL
22957	I	II	7/17/2009	TEVA PHARMACEUTICAL INDUSTRIES LTD	ARMODAFINIL
22983	A	II	7/24/2009	ACTAVIS GROUP PTC EHF	ARMODAFINIL (NON STERILE BULK DRUG SUBSTANCE)
23134	A	II	10/27/2009	LUPIN LTD	ARMODAFINIL
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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