Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 079072
Company: NORTHSTAR HLTHCARE
Company: NORTHSTAR HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GEMFIBROZIL | GEMFIBROZIL | 600MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/13/2010 | 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 |
|---|---|---|---|---|---|
| 03/08/2021 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/11/2018 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/11/2018 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/28/2016 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/15/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/15/2015 | SUPPL-5 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/07/2013 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/16/2011 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
GEMFIBROZIL
TABLET;ORAL; 600MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GEMFIBROZIL | GEMFIBROZIL | 600MG | TABLET;ORAL | Prescription | No | AB | 075034 | APOTEX |
| GEMFIBROZIL | GEMFIBROZIL | 600MG | TABLET;ORAL | Prescription | No | AB | 214603 | ASCENT PHARMS INC |
| GEMFIBROZIL | GEMFIBROZIL | 600MG | TABLET;ORAL | Prescription | No | AB | 202726 | AUROBINDO PHARMA LTD |
| GEMFIBROZIL | GEMFIBROZIL | 600MG | TABLET;ORAL | Prescription | No | AB | 203266 | CADILA PHARMS LTD |
| GEMFIBROZIL | GEMFIBROZIL | 600MG | TABLET;ORAL | Prescription | No | AB | 078012 | CARIBE HOLDINGS |
| GEMFIBROZIL | GEMFIBROZIL | 600MG | TABLET;ORAL | Prescription | No | AB | 074270 | CHARTWELL MOLECULES |
| GEMFIBROZIL | GEMFIBROZIL | 600MG | TABLET;ORAL | Prescription | No | AB | 078207 | IMPAX PHARMS |
| GEMFIBROZIL | GEMFIBROZIL | 600MG | TABLET;ORAL | Prescription | No | AB | 077836 | INVAGEN PHARMS |
| GEMFIBROZIL | GEMFIBROZIL | 600MG | TABLET;ORAL | Prescription | No | AB | 079072 | NORTHSTAR HLTHCARE |
| LOPID | GEMFIBROZIL | 600MG | TABLET;ORAL | Prescription | Yes | AB | 018422 | PFIZER PHARMS |