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Last Updated: April 16, 2024

Drug Master Files for: metaxalone

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metaxalone Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
14394	I	II	9/8/1999	DABUR INDIA LTD	MANUFACTURING SITE FACILITIES OPERATING PROCEDURES AND PERSONEL FOR G OF METAXALONE IN KALYANI DIST NADIA WEST BENGAL INDIA
14395	I	II	9/8/1999	FRESENIUS KABI ONCOLOGY LTD	METAXALONE
15087	A	II	10/11/2000	CORDEN PHARMA BERGAMO SPA	METAXALONE
15100	A	II	10/19/2000	ANGELINI ACRAF SPA	METAXALONE
15365	I	II	4/1/2001	PHARMACEUTICAL FINE CHEMICALS PFC BAHAMAS LTD	METAXALONE
15609	I	II	8/30/2001	JOHNSON MATTHEY INC	METAXALONE
16449	I	II	3/4/2003	FDC LTD	METAXALONE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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