Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018422
Company: PFIZER PHARMS
Company: PFIZER PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LOPID | GEMFIBROZIL | 200MG | CAPSULE;ORAL | Discontinued | None | No | No |
| LOPID | GEMFIBROZIL | 300MG | CAPSULE;ORAL | Discontinued | None | No | No |
| LOPID | GEMFIBROZIL | 600MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/21/1981 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/10/2020 | SUPPL-59 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018422s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/018422Orig1s059ltr.pdf | |
| 04/25/2018 | SUPPL-58 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018422s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018422Orig1s058ltr.pdf | |
| 04/18/2017 | SUPPL-56 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018422s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018422Orig1s056ltr.pdf | |
| 04/06/2016 | SUPPL-55 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018422s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018422Orig1s055ltr.pdf | |
| 11/05/2014 | SUPPL-54 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018422s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018422Orig1s054ltr.pdf | |
| 10/31/2013 | SUPPL-53 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018422s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018422Orig1s053ltr.pdf | |
| 09/27/2010 | SUPPL-50 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018422s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018422s050ltr.pdf | |
| 07/14/2009 | SUPPL-48 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018422s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018422s048ltr.pdf | |
| 03/30/2004 | SUPPL-45 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18422slr045ltr.pdf |
| 01/15/2003 | SUPPL-43 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18422slr043ltr.pdf |
| 09/26/2002 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/2001 | SUPPL-41 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18422s40s41lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18422slr043ltr.pdf | |
| 08/07/2001 | SUPPL-40 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18422s40s41lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18422slr043ltr.pdf | |
| 07/18/1997 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/24/1995 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 03/24/1995 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 12/03/1998 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 03/24/1995 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 12/02/1992 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 03/16/1992 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 01/29/1990 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/03/1990 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/30/1989 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/30/1989 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/04/1990 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 11/15/1988 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/1988 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/17/1989 | SUPPL-22 | Efficacy-New Indication |
Label is not available on this site. |
||
| 05/25/1988 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/03/1988 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/1988 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/03/1987 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1988 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/03/1987 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/26/1987 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/04/1986 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 12/10/1985 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/20/1985 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/20/1986 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/22/1984 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/26/1983 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/01/1982 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 05/05/1982 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/10/2020 | SUPPL-59 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018422s059lbl.pdf | |
| 04/25/2018 | SUPPL-58 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018422s058lbl.pdf | |
| 04/18/2017 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018422s056lbl.pdf | |
| 04/06/2016 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018422s055lbl.pdf | |
| 11/05/2014 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018422s054lbl.pdf | |
| 10/31/2013 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018422s053lbl.pdf | |
| 09/27/2010 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018422s050lbl.pdf | |
| 07/14/2009 | SUPPL-48 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018422s048lbl.pdf | |
| 08/07/2001 | SUPPL-41 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18422s40s41lbl.pdf | |
| 08/07/2001 | SUPPL-40 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18422s40s41lbl.pdf |
LOPID
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 |