Drug Master Files for: LUBIPROSTONE

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LUBIPROSTONE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
18076	A	II	2/11/2005	CATALENT PHARMA SOLUTIONS LLC	LUBIPROSTONE, 24 MCG CAPSULES
18091	A	II	2/18/2005	SUCAMPO PHARMA AMERICAS LLC	LUBIPROSTONE (RU-0211)
23383	A	II	12/17/2009	EVERLIGHT CHEMICAL INDUSTRIAL CORP	LUBIPROSTONE
23402	I	II	12/23/2009	TEVA PHARMACEUTICAL INDUSTRIES LTD	LUBIPROSTONE
23490	I	II	1/28/2010	APOTEX PHARMACHEM INC	LUBIPROSTONE
24286	I	II	11/8/2010	FIS FABBRICA ITALIANA SINTETICI SPA	LUBIPROSTONE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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