Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074270
Company: CHARTWELL MOLECULES
Company: CHARTWELL MOLECULES
| 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 |
|---|---|---|---|---|---|---|---|
| 09/27/1993 | 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 |
|---|---|---|---|---|---|
| 02/01/2024 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/21/2019 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/03/2016 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/19/2016 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/29/2005 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 10/07/1994 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/07/1994 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/1995 | SUPPL-1 | Manufacturing (CMC) |
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 |