Drug Master Files for: ZONISAMIDE
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ZONISAMIDE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
12198 | A | II | 11/1/1996 | SUMITOMO DAINIPPON PHARMA CO LTD | ZONISAMIDE DRUG SUBSTANCE |
17027 | I | II | 11/30/2003 | PERRIGO API LTD | ZONISAMIDE |
17254 | I | II | 3/26/2004 | PROCOS SPA | ZONISAMIDE |
17303 | A | II | 4/2/2004 | DIPHARMA FRANCIS SRL | ZONISAMIDE |
17661 | A | II | 9/2/2004 | JUZEN CHEMICAL CORP | ZONISAMIDE |
17945 | A | II | 12/29/2004 | GLENMARK PHARMACEUTICALS LTD | ZONISAMIDE |
17975 | I | II | 1/6/2005 | MYLAN LABORATORIES LTD | ZONISAMIDE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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