Drug Master Files for: flunisolide

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flunisolide Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11574	A	II	7/7/1995	TEVA PHARMACEUTICAL INDUSTRIES LTD	FLUNISOLIDE ANHYDROUS
11751	A	III	8/15/1996	3M DRUG DELIVERY SYSTEMS	CONTAINER CLOSURE COMPONENTS FOR HFA134A FLUNISOLIDE METERED DOSE INHALER (MDI)
16935	I	II	10/20/2003	DR REDDYS LABORATORIES LTD	FLUNISOLIDE HEMIHYDRATE
19477	A	II	5/31/2006	FARMABIOS SPA	FLUNISOLIDE ANHYDROUS USP
20375	A	II	3/26/2007	STERLING SPA	FLUNISOLIDE ANHYDROUS
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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