Drug Master Files for: abiraterone acetate

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abiraterone acetate Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
26725	A	II	11/28/2012	STERLING SPA	ABIRATERONE ACETATE
26779	A	II	12/24/2012	CHONGQING PHARMACEUTICAL RESEARCH INSTITUTE CO LTD	ABIRATERONE ACETATE (NON-STERILE BULK DRUG SUBSTANCE)
26894	A	II	7/30/2014	CHEMWERTH INC	ABIRATERONE ACETATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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