Drug Master Files for: fluconazole
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fluconazole Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11524 | I | II | 5/24/1995 | CIPLA LTD | FLUCONAZOLE USP |
| 14419 | I | II | 9/23/1999 | CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD | FLUCONAZOLE |
| 14714 | A | II | 12/15/1999 | INKE SA | FLUCONAZOLE |
| 14863 | I | II | 5/2/2000 | WOCKHARDT LTD | FLUCONAZOLE |
| 15045 | A | II | 8/11/2000 | MYLAN LABORATORIES LTD | FLUCONAZOLE USP |
| 15161 | A | II | 11/27/2000 | CIPLA LTD | FLUCONAZOLE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
