Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206045
Company: KENTON
Company: KENTON
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RILUZOLE | RILUZOLE | 50MG | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/09/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/17/2023 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
RILUZOLE
TABLET;ORAL; 50MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
RILUZOLE | RILUZOLE | 50MG | TABLET;ORAL | Prescription | No | AB | 204048 | ALKEM LABS LTD |
RILUZOLE | RILUZOLE | 50MG | TABLET;ORAL | Prescription | No | AB | 091394 | GLENMARK PHARMS LTD |
RILUZOLE | RILUZOLE | 50MG | TABLET;ORAL | Prescription | No | AB | 076173 | IMPAX LABS |
RILUZOLE | RILUZOLE | 50MG | TABLET;ORAL | Prescription | No | AB | 206045 | KENTON |
RILUZOLE | RILUZOLE | 50MG | TABLET;ORAL | Prescription | No | AB | 203042 | MYLAN PHARMS INC |
RILUZOLE | RILUZOLE | 50MG | TABLET;ORAL | Prescription | No | AB | 091417 | SUN PHARM INDS LTD |