Drug Master Files for: Abraxis Bioscience

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Abraxis Bioscience Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
28533	A	II	6/10/2015	ABRAXIS BIOSCIENCE LLC A WHOLLY OWNED SUB OF CELGENE CORP	IDN 5404 ALBUMIN-BOUND PARTICLES FOR INJECTABLE SUSPENSION (COMPANY CODE: ABI-011)
28535	A	II	4/14/2015	ABRAXIS BIOSCIENCE LLC A WHOLLY OWNED SUB OF CELGENE CORP	RAPAMYCIN PROTEIN BOUND PARTICLE FOR INJECTABLE SUSPENSION (COMPANY CODE: ABI-009)
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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