Drug Master Files for: dexamethasone

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dexamethasone Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
1095	I	II	11/2/1967	SF DURST AND CO INC	DEXAMETHASONE
1142	I	II	2/9/1968	DBI INC	DEXAMETHASONE ACETATE
11587	I	II	7/17/1995	HOECHST MARION ROUSSEL SA	DEXAMETHASONE ACETATE USP MONOHYDRATE
1343	I	II	3/14/1969	ORGANON INC	DEXAMETHASONE 21-TERTIARY BUTYLACETATE
17141	A	II	2/4/2004	TIANJIN TIANYAO PHARMACEUTICALS CO LTD	DEXAMETHASONE, USP
1748	A	II	6/21/1971	SANOFI CHIMIE	DEXAMETHASONE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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