Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075034
Company: APOTEX
Company: APOTEX
| 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 |
|---|---|---|---|---|---|---|---|
| 07/20/1998 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75034ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75034_Gemfibrozil.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/30/2021 | SUPPL-31 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/19/2019 | SUPPL-29 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2017 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/03/2016 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/08/2015 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/08/2015 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/14/2011 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/22/2010 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/21/2006 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 08/01/2005 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 11/04/2005 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 03/25/2002 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 01/31/2002 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/2001 | SUPPL-1 | Labeling |
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 |