Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 079239
Company: SUN PHARM INDS INC
Company: SUN PHARM INDS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GEMFIBROZIL | GEMFIBROZIL | 600MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 12/29/2008 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/04/2015 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/04/2015 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/27/2011 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/15/2009 | SUPPL-4 | Labeling-Container/Carton Labels |
Label is not available on this site. |