Drug Master Files for: eletriptan hydrobromide
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eletriptan hydrobromide Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 22912 | A | II | 6/29/2009 | TEVA PHARMACEUTICAL INDUSTRIES LTD | ELETRIPTAN HYDROBROMIDE |
| 23651 | I | II | 3/25/2010 | APOTEX PHARMACHEM INDIA PVT LTD | ELETRIPTAN HYDROBROMIDE |
| 24504 | A | II | 12/28/2010 | MYLAN LABORATORIES LTD | ELETRIPTAN HYDROBROMIDE (PROCESS 1) |
| 24528 | A | II | 12/29/2010 | FIS FABBRICA ITALIANA SINTETICI SPA | ELETRIPTAN HYDROBROMIDE |
| 24905 | A | II | 5/2/2011 | SMS PHARMACEUTICALS LTD | ELETRIPTAN HYDROBROMIDE MONOHYDRATE |
| 25076 | A | II | 6/27/2011 | MYLAN LABORATORIES LTD | ELETRIPTAN HYDROBROMIDE (PROCESS 2) |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
