Drug Master Files for: BUTOCONAZOLE NITRATE
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BUTOCONAZOLE NITRATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 13106 | I | II | 7/6/1998 | QUIMICA SINTETICA SA | BUTOCONAZOLE NITRATE |
| 15929 | I | II | 4/8/2002 | GEDEON RICHTER PLC | BUTOCONAZOLE NITRATE |
| 17944 | I | II | 12/3/2004 | HONEYWELL IROPHARM PLC | BUTOCONAZOLE |
| 18981 | A | II | 11/29/2005 | DERIVADOS QUIMICOS SAU | BUTOCONAZOLE NITRATE |
| 3351 | I | II | 10/31/1978 | ROCHE PALO ALTO LLC | BUTOCONAZOLE NITRATE |
| 9585 | I | II | 3/19/1992 | KV PHARMACEUTICAL CO | BUTOCONAZOLE NITRATE 2% VAGINAL CREAM |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
