Drug Master Files for: PREDNISOLONE ACETATE
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PREDNISOLONE ACETATE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
11218 | I | II | 10/7/1994 | TIANJIN PHARMACEUTICAL CORP | PREDNISOLONE |
1432 | I | II | 9/18/1969 | PHARMACIA AND UPJOHN SUB PFIZER INC | PREDNISOLONE USP |
1454 | I | II | 12/12/1969 | UPJOHN CO | FLUPREDNISOLONE & FLUPREDNISOLONE ACETATE |
15652 | I | II | 10/8/2001 | SANOFI CHIMIE | PREDNISOLONE SODIUM METASULFOBENZOATE |
15912 | I | II | 3/25/2002 | PHARMACIA AND UPJOHN SUB PFIZER INC | METHYLPREDNISOLONE 100MG TABLETS |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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