Drug Master Files for: TOLMETIN SODIUM

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TOLMETIN SODIUM Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
16432	I	II	2/17/2003	AMSA SPA	TOLMETIN SODIUM
22092	A	II	10/16/2008	MYLAN LABORATORIES LTD	TOLMETIN SODIUM USP
2294	I	II	6/24/1974	ETHYL CORP	TOLMETIN (MCN2559-21-98)
2514	I	II	8/22/1975	ETHYL CORP	TOLMETIN (MCN 2559-21-98)
2537	I	II	10/21/1975	CILAG CHEMIE AG	TOLMETIN SODIUM DIHYDRATE
2763	I	II	9/27/1976	MALLINCKRODT INC	TOLMETIN SODIUM DIHYDRATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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