Drug Master Files for: Celgene Corp

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Celgene Corp Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
12079	I	II	8/7/1996	CELGENE CORP	FR901228
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)
30795	A	V	8/31/2016	CELGENE CORP	LENALIDOMIDE REMS HOSTED SYSTEM
32253	A	V	5/31/2018	CELGENE CORP	THALIDOMIDE REMS HOSTED SYSTEM
32574	A	II	5/4/2018	CELGENE CORP	MARIZOMIB, A LYOPHILIZED POWDER FOR INJECTION WITH ACCOMPANYING DILUENT
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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