Drug Master Files for: sumatriptan
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sumatriptan Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
15376 | A | II | 4/5/2001 | QUIMICA SINTETICA SA | SUMATRIPTAN SUCCINATE |
16279 | A | II | 12/2/2002 | SMS PHARMACEUTICALS LTD | SUMATRIPTAN SUCCINATE |
16534 | A | II | 3/21/2003 | DR REDDYS LABORATORIES LTD | SUMATRIPTAN SUCCINATE |
16903 | I | II | 10/20/2003 | QUIMICA SINTETICA SA | SUMATRIPTAN |
16930 | A | II | 10/23/2003 | NATCO PHARMA LTD | SUMATRIPTAN SUCCINATE |
17352 | A | II | 4/29/2004 | MOEHS IBERICA SL | SUMATRIPTAN SUCCINATE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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