Drug Master Files for: topiramate
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topiramate Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10919 | A | II | 5/27/1994 | JANSSEN PHARMACEUTICA NV | TOPIRAMATE DRUG SUBSTANCE |
| 10978 | I | II | 7/8/1994 | CILAG AG | TOPIRAMATE |
| 15658 | I | II | 10/8/2001 | FERRO PFANSTIEHL LABORATORIES INC | TOPIRAMATE |
| 15693 | A | II | 10/31/2001 | CIPLA LTD | TOPIRAMATE USP |
| 16405 | I | II | 1/30/2003 | ALKALOIDA CHEMICAL CO ZRT | TOPIRAMATE |
| 16533 | A | II | 3/21/2003 | DR REDDYS LABORATORIES LTD | TOPIRAMATE USP |
| 17035 | A | II | 12/16/2003 | SCINOPHARM TAIWAN LTD | TOPIRAMATE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
