Drug Master Files for: MYCOPHENOLATE MOFETIL

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MYCOPHENOLATE MOFETIL Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
16406	A	II	1/20/2003	BIOCON LTD	MYCOPHENOLATE MOFETIL
18494	A	II	7/11/2005	CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD	MYCOPHENOLATE MOFETIL USP
18936	I	II	11/7/2005	LEK PHARMACEUTICALS DD	MYCOPHENOLATE MOFETIL
18989	I	II	11/28/2005	IVAX PHARMACEUTICALS SRO	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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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