Drug Master Files for: METHYLPREDNISOLONE

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METHYLPREDNISOLONE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
15912	I	II	3/25/2002	PHARMACIA AND UPJOHN SUB PFIZER INC	METHYLPREDNISOLONE 100MG TABLETS
17547	A	II	7/19/2004	TIANJIN TIANYAO PHARMACEUTICALS CO LTD	METHYLPREDNISOLONE USP
18956	A	II	1/5/2006	TIANJIN TIANYAO PHARMACEUTICALS CO LTD	METHYLPREDNISOLONE ACETATE (BULK) USP
20310	A	II	2/27/2007	TEVA PHARMACEUTICAL INDUSTRIES LTD	METHYLPREDNISOLONE HEMISUCCINATE, BULK INTERMEDIATE
22575	A	II	2/26/2009	NEWCHEM SPA	METHYLPREDNISOLONE HEMISUCCINATE
22904	A	II	6/29/2009	SYMBIOTEC PHARMALAB PRIVATE LTD	METHYLPREDNISOLONE HEMISUCCINATE
23820	A	II	5/19/2010	CRYSTAL PHARMA SAU	METHYLPREDNISOLONE ACETATE STERILE MICRONIZED
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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