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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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