U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 017604
Company: KEY THERAP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NALFON FENOPROFEN CALCIUM EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE;ORAL Discontinued None No No
NALFON FENOPROFEN CALCIUM EQ 200MG BASE CAPSULE;ORAL Discontinued None Yes No
NALFON FENOPROFEN CALCIUM EQ 400MG BASE CAPSULE;ORAL Discontinued None Yes No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
04/28/2021 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017604s051lbl.pdf
04/28/2021 SUPPL-51 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017604s051lbl.pdf
05/09/2016 SUPPL-46 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017604s046lbl.pdf
05/09/2016 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017604s046lbl.pdf
05/09/2016 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017604s046lbl.pdf
07/21/2009 SUPPL-43 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017604s043lbl.pdf
07/21/2009 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017604s043lbl.pdf
08/07/2007 SUPPL-41 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017604s041lbl.pdf
01/18/2006 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017604s040lbl.pdf
Back to Top