Drug Master Files for: SALMETEROL XINAFOATE

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SALMETEROL XINAFOATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
15706	I	II	11/8/2001	CIPLA LTD	SALMETEROL XINAFOATE
18378	A	II	5/26/2005	CIPLA LTD	SALMETEROL XINAFOATE
18394	A	II	6/3/2005	NATCO PHARMA LTD	SALMETEROL XINAFOATE
21859	A	II	8/5/2008	MYLAN LABORATORIES LTD	SALMETEROL XINAFOATE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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