Drug Master Files for: SIBUTRAMINE HYDROCHLORIDE

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SIBUTRAMINE HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
17171	I	II	2/11/2004	OLON SPA	SIBUTRAMINE HYDROCHLORIDE ANHYDROUS
17977	I	II	1/6/2005	MYLAN LABORATORIES LTD	SIBUTRAMINE HYDROCHLORIDE MONOHYDRATE
19729	I	II	9/4/2006	DIVIS LABORATORIES LTD	SIBUTRAMINE HYDROCHLORIDE MONOHYDRATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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