Drug Master Files for: METHYLPREDNISOLONE
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METHYLPREDNISOLONE Drug Master Files
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 |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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