Drug Master Files for: ROPIVACAINE HYDROCHLORIDE

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ROPIVACAINE HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
18288	A	II	4/15/2005	EXCELLA GMBH AND CO KG	ROPIVACAINE HYDROCHLORIDE
19084	A	II	12/30/2005	NAVINTA LLC	ROPIVACAINE
20249	A	II	2/2/2007	CHEMWERTH INC	ROPIVACAINE HCL MONOHYDRATE
20654	A	II	7/3/2007	FINE CHEMICALS CORP PTY LTD	ROPIVACAINE HYDROCHLORIDE
22023	A	II	9/22/2008	DISHMAN CARBOGEN AMCIS LTD	ROPIVACAINE HYDROCHLORIDE ANHYDROUS
23239	A	II	11/2/2009	FINE CHEMICALS CORP PTY LTD	ROPIVACAINE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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