Drug Master Files for: PHENYTOIN
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PHENYTOIN Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 16301 | A | II | 12/5/2002 | ERREDUE SPA INNOVATIVE CHEMICAL AND LIFE | PHENYTOIN SODIUM |
| 16899 | I | II | 10/8/2003 | RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA | FOSPHENYTOIN SODIUM API |
| 17333 | A | II | 4/26/2004 | SHANGHAI ZIYUAN PHARMACEUTICAL CO LTD | FOSPHENYTOIN SODIUM USP |
| 17862 | A | II | 12/2/2004 | HARMAN FINOCHEM LTD | PHENYTOIN SODIUM USP |
| 18806 | A | II | 9/25/2005 | DIVIS LABORATORIES LTD | FOSPHENYTOIN SODIUM USP |
| 18954 | I | II | 11/14/2005 | CILAG AG | FOSPHENYTOIN SODIUM DRUG SUBSTANCE (A PHARMACEUTICAL INGREDIENT) |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
