Drug Master Files for: ENZALUTAMIDE

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ENZALUTAMIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
29062	A	II	3/23/2015	SAI LIFE SCIENCES LTD	4-((2-CYANOPROPAN-2-YL)AMINO)-2-FLUORO-N-METHYLBENZAMIDE (ENZALUTAMIDE INTERMEDIATE)
29117	A	II	3/31/2015	DR REDDYS LABORATORIES LTD	ENZALUTAMIDE
29872	A	II	5/24/2016	TEVA PHARMACEUTICAL INDUSTRIES LTD	ENZALUTAMIDE
30010	A	II	11/28/2015	MYLAN LABORATORIES LTD	ENZALUTAMIDE
30260	A	II	3/17/2016	SHILPA MEDICARE LTD	ENZALUTAMIDE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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