Drug Master Files for: riluzole
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riluzole Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 15252 | A | II | 1/16/2001 | SCINOPHARM TAIWAN LTD | RILUZOLE |
| 22107 | A | II | 10/22/2008 | GLENMARK PHARMACEUTICALS LTD | RILUZOLE USP |
| 22438 | A | II | 3/16/2009 | SUN PHARMACEUTICAL INDUSTRIES LTD | RILUZOLE USP |
| 22596 | A | II | 3/5/2009 | APOTEX PHARMACHEM INDIA PVT LTD | RILUZOLE USP |
| 23215 | A | II | 10/26/2009 | HETERO DRUGS LTD | RILUZOLE |
| 23569 | I | II | 2/24/2010 | DR REDDYS LABORATORIES LTD | RILUZOLE |
| 24693 | A | II | 2/28/2011 | ESTEVE QUIMICA SA | RILUZOLE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
