Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209325
Company: BRECKENRIDGE
Company: BRECKENRIDGE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MIGLUSTAT | MIGLUSTAT | 100MG | 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 |
---|---|---|---|---|---|---|---|
02/03/2022 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
MIGLUSTAT
CAPSULE;ORAL; 100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MIGLUSTAT | MIGLUSTAT | 100MG | CAPSULE;ORAL | Prescription | No | AB | 208342 | ANI PHARMS |
MIGLUSTAT | MIGLUSTAT | 100MG | CAPSULE;ORAL | Prescription | No | AB | 209325 | BRECKENRIDGE |
YARGESA | MIGLUSTAT | 100MG | CAPSULE;ORAL | Prescription | No | AB | 209821 | EDENBRIDGE PHARMS |
ZAVESCA | MIGLUSTAT | 100MG | CAPSULE;ORAL | Prescription | Yes | AB | 021348 | ACTELION |