Drug Master Files for: PROBUCOL
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PROBUCOL Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 17355 | A | II | 4/26/2004 | SCI PHARMTECH INC | PROBUCOL |
| 2167 | I | II | 10/17/1973 | HOECHST MARION ROUSSEL INC | PROBUCOL (DH-581) |
| 7579 | I | II | 7/18/1988 | MEDICHEM SA | PROBUCOL |
| 7761 | I | II | 11/22/1988 | SUMIKA FINE CHEMICALS CO LTD | PROBUCOL |
| 8258 | I | II | 10/20/1989 | WYCKOFF CHEMICAL CO INC | PROBUCOL |
| 8286 | I | II | 11/14/1989 | ZAMBON SPA | PROBUCOL 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
