Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018422
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
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
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 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 078599 HIKMA PHARMS
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
GEMFIBROZIL GEMFIBROZIL 600MG TABLET;ORAL Prescription No AB 079239 SUN PHARM INDS INC
GEMFIBROZIL GEMFIBROZIL 600MG TABLET;ORAL Prescription No AB 074256 TEVA
LOPID GEMFIBROZIL 600MG TABLET;ORAL Prescription Yes AB 018422 PFIZER PHARMS

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