Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204475
Company: MYLAN PHARMS INC
Company: MYLAN PHARMS INC
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 |
---|---|---|---|---|---|---|---|
06/23/2016 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204475Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204475Orig1s000ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/23/2016 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204475Orig1s000lbl.pdf |
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 | 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 | 204475 | MYLAN PHARMS INC |
FENOGLIDE | FENOFIBRATE | 120MG | TABLET;ORAL | Prescription | Yes | AB | 022118 | SALIX |
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