Drug Master Files for: ORLISTAT

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ORLISTAT Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
18315	A	III	4/28/2005	NYPRO INC	ORLISTAT 60 MG PORTABLE PACKAGE (R)
22110	I	II	10/24/2008	ZHEJIANG HISUN PHARMACEUTICAL CO LTD	ORLISTAT
22357	I	II	12/30/2008	SUN PHARMACEUTICAL INDUSTRIES LTD	ORLISTAT (NON-STERILE BULK)
23978	A	II	7/19/2010	FORMOSA LABORATORIES INC	ORLISTAT 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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