Drug Master Files for: FLUOROMETHOLONE

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FLUOROMETHOLONE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
1541	I	II	6/25/1970	PHARMACIA AND UPJOHN	FLUOROMETHOLONE MICRONIZED
3786	I	II	3/24/1980	ANTIBIOTICOS SPA	FLUOROMETHOLONE 17-ACETATE NON-MICRONIZED AND MICRONIZED
4423	A	II	2/3/1982	SANOFI CHIMIE	FLUOROMETHOLONE
4761	I	II	12/17/1982	SICOR SPA	FLUOROMETHOLONE
5684	A	II	9/4/1984	TEVA PHARMACEUTICAL INDUSTRIES LTD	FLUOROMETHOLONE-17-ACETATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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