Drug Master Files for: BUPIVACAINE

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BUPIVACAINE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11938	A	II	4/18/1996	SIEGFRIED EVIONNAZ SA	BUPIVACAINE BASE
19177	A	II	2/10/2006	CAMBREX KARLSKOGA AB	BUPIVACAINE BASE
20959	A	II	10/18/2007	DISHMAN CARBOGEN AMCIS LTD	BUPIVACAINE HYDROCHLORIDE
21196	A	II	12/20/2007	EXCELLA GMBH AND CO KG	Bupivacaine Hydrochloride
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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