Drug Master Files for: darunavir

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darunavir Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
18825	A	II	11/2/2005	JANSSEN PHARMACEUTICA NV	DARUNAVIR (R319064) DRUG SUBSTANCE
23660	A	II	3/16/2011	CIPLA LTD	DARUNAVIR
23661	A	II	7/6/2010	CIPLA LTD	DARUNAVIR HYDRATE
23662	A	II	6/15/2010	CIPLA LTD	DARUNAVIR ETHANOLATE
23850	A	II	2/10/2011	LUPIN LTD	DARUNAVIR ETHANOLATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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