Drug Master Files for: MODAFINIL

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MODAFINIL Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11806	I	II	1/15/1996	ORSYMONDE	MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF MODAFINIL DRUG SUBSTANCE IN MITRY-MORY MITRY-MORY CEDEX FRANCE.
11970	A	II	5/15/1996	CEPHALON INC	MODAFINIL DRUG SUBSTANCE
16140	I	II	9/19/2002	WAVELENGTH ENTERPRISES LTD	MODAFINIL
16250	A	II	11/19/2002	DIPHARMA FRANCIS SRL	MODAFINIL USP
16306	A	II	12/12/2002	MYLAN LABORATORIES LTD	MODAFINIL USP
16310	A	II	12/13/2002	TEVA PHARMACEUTICAL INDUSTRIES LTD	MODAFINIL
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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