Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212463
Company: AIZANT
Company: AIZANT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ELIGLUSTAT TARTRATE | ELIGLUSTAT TARTRATE | EQ 84MG BASE | CAPSULE;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 |
---|---|---|---|---|---|---|---|
09/08/2021 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212463Orig1s000ltr.pdf |
ELIGLUSTAT TARTRATE
CAPSULE;ORAL; EQ 84MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CERDELGA | ELIGLUSTAT TARTRATE | EQ 84MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 205494 | GENZYME CORP |
ELIGLUSTAT TARTRATE | ELIGLUSTAT TARTRATE | EQ 84MG BASE | CAPSULE;ORAL | Prescription | No | AB | 212463 | AIZANT |
ELIGLUSTAT TARTRATE | ELIGLUSTAT TARTRATE | EQ 84MG BASE | CAPSULE;ORAL | Prescription | No | AB | 212420 | UPSHER SMITH LABS |