Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200913
Company: MYLAN PHARMS INC
Company: MYLAN PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FENOFIBRIC ACID | CHOLINE FENOFIBRATE | EQ 45MG FENOFIBRIC ACID | CAPSULE, DELAYED RELEASE;ORAL | Discontinued | None | No | No |
| FENOFIBRIC ACID | CHOLINE FENOFIBRATE | EQ 135MG FENOFIBRIC ACID | CAPSULE, DELAYED RELEASE;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 03/25/2013 | ORIG-1 | Approval | Not Applicable |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200913Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/19/2019 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/19/2019 | SUPPL-5 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/06/2015 | SUPPL-2 | Labeling-Medication Guide |
Label is not available on this site. |
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