Drug Master Files for: Concord Biotech Ltd

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Concord Biotech Ltd Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
17393	A	II	5/17/2004	CONCORD BIOTECH LTD	LOVASTATIN USP
18908	A	II	10/24/2005	CONCORD BIOTECH LTD	TACROLIMUS USP
19044	I	II	12/13/2005	CONCORD BIOTECH LTD	SIMVASTATIN USP
19231	A	II	3/7/2006	CONCORD BIOTECH LTD	MYCOPHENOLATE MOFETIL 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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