Drug Master Files for: dorzolamide hydrochloride

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dorzolamide hydrochloride Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
18385	A	II	5/31/2005	CRYSTAL PHARMA SAU	DORZOLAMIDE HYDROCHLORIDE
20284	I	II	2/15/2007	USV LTD	DORZOLAMIDE HYDROCHLORIDE USP
20441	A	II	4/19/2007	TEVA PHARMACEUTICAL INDUSTRIES LTD	DORZOLAMIDE HCL
20740	A	II	7/27/2007	FIS FABBRICA ITALIANA SINTETICI SPA	DORZOLAMIDE HYDROCHLORIDE
20856	A	II	9/17/2007	FDC LTD	DORZOLAMIDE HYDROCHLORIDE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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