Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 217732
Company: CREEKWOOD PHARMS
Company: CREEKWOOD PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FENOFIBRATE | FENOFIBRATE | 40MG | TABLET;ORAL | Prescription | AB | No | No |
FENOFIBRATE | FENOFIBRATE | 120MG | 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 |
---|---|---|---|---|---|---|---|
09/07/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
FENOFIBRATE
TABLET;ORAL; 40MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FENOFIBRATE | FENOFIBRATE | 40MG | TABLET;ORAL | Prescription | No | AB | 217732 | CREEKWOOD PHARMS |
FENOFIBRATE | FENOFIBRATE | 40MG | TABLET;ORAL | Prescription | No | AB | 204475 | MYLAN PHARMS INC |
FENOGLIDE | FENOFIBRATE | 40MG | TABLET;ORAL | Prescription | Yes | AB | 022118 | SALIX |
TABLET;ORAL; 120MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FENOFIBRATE | FENOFIBRATE | 120MG | TABLET;ORAL | Prescription | No | AB | 217732 | CREEKWOOD PHARMS |
FENOFIBRATE | FENOFIBRATE | 120MG | TABLET;ORAL | Prescription | No | AB | 204475 | MYLAN PHARMS INC |
FENOGLIDE | FENOFIBRATE | 120MG | TABLET;ORAL | Prescription | Yes | AB | 022118 | SALIX |