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Drugs@FDA: FDA-Approved Drugs

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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

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
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