Drug Master Files for: unoprostone isopropyl

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unoprostone isopropyl Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
14611	I	II	12/7/1999	R TECH UENO LTD	UNOPROSTONE ISOPROPYL
22987	I	II	7/29/2009	R TECH UENO LTD	UNOPROSTONE ISOPROPYL OPHTHALMIC SOLUTION 0.15%
27235	I	II	6/11/2013	YONSUNG FINE CHEMICALS CO LTD	ISOPROPYL UNOPROSTONE
28339	A	II	6/17/2014	CHIROGATE INTERNATIONAL INC	UNOPROSTONE ISOPROPYL
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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