Drug Master Files for: dexamethasone
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dexamethasone Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 1095 | I | II | 11/2/1967 | SF DURST AND CO INC | DEXAMETHASONE |
| 1142 | I | II | 2/9/1968 | DBI INC | DEXAMETHASONE ACETATE |
| 11587 | I | II | 7/17/1995 | HOECHST MARION ROUSSEL SA | DEXAMETHASONE ACETATE USP MONOHYDRATE |
| 1343 | I | II | 3/14/1969 | ORGANON INC | DEXAMETHASONE 21-TERTIARY BUTYLACETATE |
| 17141 | A | II | 2/4/2004 | TIANJIN TIANYAO PHARMACEUTICALS CO LTD | DEXAMETHASONE, USP |
| 1748 | A | II | 6/21/1971 | SANOFI CHIMIE | DEXAMETHASONE |
| 2205 | I | II | 12/31/1973 | ANTIBIOTICOS SPA | DEXAMETHASONE, NON-STERILE (BULK) |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
