Application Number | Application Type | Drug Name | Active Ingredients | Dosage Form/Route | Approval Date | Company |
---|---|---|---|---|---|---|
216035 | ANDA | RILUZOLE | RILUZOLE | SUSPENSION;ORAL | ALKEM LABS LTD | |
212640 | NDA | EXSERVAN | RILUZOLE | FILM;ORAL | 2019-11-22 | AQUESTIVE |
209080 | NDA | TIGLUTIK KIT | RILUZOLE | SUSPENSION;ORAL | 2018-09-05 | ITALFARMACO SA |
206045 | ANDA | RILUZOLE | RILUZOLE | TABLET;ORAL | 2019-12-09 | KENTON |
204430 | ANDA | RILUZOLE | RILUZOLE | TABLET;ORAL | 2018-10-16 | DAITO PHARMS CO LTD |
204048 | ANDA | RILUZOLE | RILUZOLE | TABLET;ORAL | 2016-03-30 | ALKEM LABS LTD |
203042 | ANDA | RILUZOLE | RILUZOLE | TABLET;ORAL | 2013-07-01 | NORVIUM BIOSCIENCE |
091417 | ANDA | RILUZOLE | RILUZOLE | TABLET;ORAL | 2013-06-18 | SUN PHARM INDS LTD |
091394 | ANDA | RILUZOLE | RILUZOLE | TABLET;ORAL | 2013-06-18 | GLENMARK PHARMS LTD |
091300 | ANDA | RILUZOLE | RILUZOLE | TABLET;ORAL | 2013-06-18 | APOTEX CORP |
076173 | ANDA | RILUZOLE | RILUZOLE | TABLET;ORAL | 2003-01-29 | IMPAX LABS |
020599 | NDA | RILUTEK | RILUZOLE | TABLET;ORAL | 1995-12-12 | COVIS |