Drug Master Files for: formoterol fumarate

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formoterol fumarate Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
12380	I	II	2/24/1997	ASTELLAS PHARMA INC	FORMOTEROL FUMARATE
12426	I	II	3/19/1997	YAMANOUCHI IRELAND CO LTD	FORMOTEROL FUMERATE
14154	I	II	5/25/1999	INDUSTRIALE CHIMICA SRL	FORMOTEROL FUMARATE DIHYDRATE MICRONIZED
16241	I	II	11/13/2002	SICOR SWISS BRANCH	FORMOTEROL FUMARATE
16628	A	II	6/3/2003	INKE SA	FORMOTEROL FUMARATE
19023	A	III	12/9/2005	3M DRUG DELIVERY SYSTEMS DIV	MOMETASONE & FORMOTEROL COMBINATION PRODUCT PMDI ACTUATOR
19202	A	II	2/21/2006	MYLAN LABORATORIES LTD	FORMOTEROL FUMARATE DIHYDRATE USP
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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