Drug Master Files for: CYCLOSPORINE

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CYCLOSPORINE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10281	I	II	6/8/1993	NORTH CHINA PHARMACEUTICAL CORP	CYCLOSPORINE, USP (BULK, NON-STERILE)
11618	I	II	8/7/1995	SANDOZ PHARMA LTD	CYCLOSPORINE MANFACTURED IN BASLE, SWITZERLAND.
11971	I	II	5/13/1996	GALENA AS	CYCLOSPORINE
12214	A	II	10/25/1996	CKD BIO CORP	CYCLOSPORINE, NON-STERILE BULK, USP
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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