Drug Master Files for: hydrocortisone
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hydrocortisone Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10447 | I | II | 8/26/1993 | PHARMACIA AND UPJOHN SUB PFIZER INC | HYDROCORTISONE BUTYRATE |
| 11606 | A | II | 7/27/1995 | SHANDONG XINHUA PHARMACEUTICAL CO LTD | HYDROCORTISONE |
| 117 | I | II | 9/11/1953 | PASADENA RESEARCH LABORATORIES INC | HYDROCORTISONE ACETATE |
| 13921 | A | II | 12/30/1998 | TARO PHARMACEUTICAL INDUSTRIES LTD | HYDROCORTISONE 17-VALERATE, USP |
| 1413 | A | II | 9/2/1969 | PHARMACIA AND UPJOHN CO LLC WHOLLY OWNED SUB OF PFIZER INC | HYDROCORTISONE MICRONIZED AND NON-MICRONIZED |
| 15750 | A | II | 12/6/2001 | TARO PHARMACEUTICAL INDUSTRIES LTD | HYDROCORTISONE 17-BUTYRATE, USP |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
