Drug Master Files for: PREDNISONE
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PREDNISONE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11289 | A | II | 10/7/1994 | TIANJIN TIANYAO PHARMACEUTICALS CO LTD | PREDNISONE USP |
| 13173 | A | II | 8/6/1998 | CRYSTAL PHARMA SAU | PREDNISONE ANHYDROUS USP, |
| 13950 | A | II | 1/19/1999 | TIANJIN TIANYAO PHARMACEUTICALS CO LTD | PREDNISONE ACETATE USP |
| 1412 | I | II | 9/2/1969 | PHARMACIA AND UPJOHN CO WHOLLY OWNED SUB PFIZER INC | PREDNISONE MICRONIZED, STERILIZED AND ACETATE |
| 16000 | A | II | 6/10/2002 | HIKMA PHARMACEUTICALS | PREDNISONE ANHYDROUS USP |
| 241 | I | II | 1/29/1957 | SYNTEX LABORATORIES INC SUB SYNTEX CORP | PREDNISONE, CRUDE AND CRYSTALLINE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
