Drug Master Files for: NEBIVOLOL HYDROCHLORIDE

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NEBIVOLOL HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
15417	A	II	5/7/2001	JANSSEN PHARMACEUTICA NV	NEBIVOLOL HYDROCHLORIDE(R067555) DRUG SUBSTANCE AS
21152	A	II	12/8/2007	CADILA PHARMACEUTICALS LTD	Nebivolol Hydrochloride
22735	A	II	3/31/2009	FIS FABBRICA ITALIANA SINTETICI SPA	NEBIVOLOL 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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