Drug Master Files for: LATANOPROST

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LATANOPROST Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
15462	I	II	5/31/2001	RESOLUTION CHEMICALS LTD	LATANOPROST
17445	A	II	6/1/2004	CAYMAN CHEMICAL CO	LATANOPROST DRUG SUBSTANCE
18343	A	II	5/24/2005	CHIROGATE INTERNATIONAL INC	LATANOPROST
19535	A	II	6/20/2006	FINETECH PHARMACEUTICAL LTD	LATANOPROST DRUG SUBSTANCE
20925	I	II	10/5/2007	SAI LIFE SCIENCES LTD	LATANOPROST, NON-STERILE BULK DRUG SUBSTANCE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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