Drug Master Files for: bicalutamide

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bicalutamide Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
17008	A	II	12/5/2003	TEVA PHARMACEUTICAL INDUSTRIES LTD	BICALUTAMIDE
17878	A	II	12/3/2004	ZHEJIANG HISUN PHARMACEUTICAL CO LTD	BICALUTAMIDE USP
18141	I	II	3/3/2005	CF PHARMA LTD	BICALUTAMIDE
18374	A	II	5/26/2005	USV PRIVATE LTD	BICALUTAMIDE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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