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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018936
Company: ELI LILLY AND CO

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROZAC FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Discontinued None Yes No
PROZAC FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Discontinued None Yes No
PROZAC FLUOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE;ORAL Discontinued None No No
PROZAC FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Discontinued None Yes No
SARAFEM FLUOXETINE HYDROCHLORIDE EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE;ORAL Discontinued None Yes No
SARAFEM FLUOXETINE HYDROCHLORIDE EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE;ORAL Discontinued None Yes No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
08/18/2023 SUPPL-112 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018936 s112lbl.pdf
08/18/2023 SUPPL-112 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018936 s112lbl.pdf
10/06/2021 SUPPL-111 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018936s111lbl.pdf
10/06/2021 SUPPL-111 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018936s111lbl.pdf
04/28/2020 SUPPL-109 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018936s109lbl.pdf
03/24/2017 SUPPL-103 Labeling-Package Insert Label (PDF) Label for PROZAC https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018936s103,021235s023lbl.pdf
01/04/2017 SUPPL-108 Labeling-Medication Guide Label (PDF) Label for PROZAC https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018936s108lbl.pdf
10/10/2014 SUPPL-102 Efficacy-Labeling Change With Clinical Data Label (PDF) Label for PROZAC https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018936s102lbl.pdf
07/18/2014 SUPPL-105 Labeling-Package Insert Label (PDF) Label for PROZAC https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018936s105,021235s024lbl.pdf
07/26/2013 SUPPL-101 Efficacy-Pediatric Label (PDF) Label for PROZAC https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s100s101,021235s021lbl.pdf
07/26/2013 SUPPL-100 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s100s101,021235s021lbl.pdf
01/03/2013 SUPPL-98 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s097s098,021235s019s020lbl.pdf
01/03/2013 SUPPL-97 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s097s098,021235s019s020lbl.pdf
06/15/2011 SUPPL-96 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s096,021235s018lbl.pdf
04/04/2011 SUPPL-95 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s095lbl.pdf
04/04/2011 SUPPL-93 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s093lbl.pdf
04/04/2011 SUPPL-91 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s091lbl.pdf
06/22/2009 SUPPL-89 Labeling Label (PDF) Label for SARAFEM https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s089lbl.pdf
03/19/2009 SUPPL-77 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s075s077lbl.pdf
03/19/2009 SUPPL-77 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s075s077lbl.pdf
03/19/2009 SUPPL-75 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s075s077lbl.pdf
01/30/2009 SUPPL-88 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s088,020101s042,021235s014lbl.pdf
06/26/2008 SUPPL-86 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018936s086lbl.pdf
03/21/2008 SUPPL-84 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018936s084,020101s039,021235s011lbl.pdf
03/09/2008 SUPPL-83 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018936s083,020101s038,021235s010lbl.pdf
08/02/2007 SUPPL-82 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018936s081s082,020101s037,021235s009lbl.pdf
08/02/2007 SUPPL-81 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018936s081s082,020101s037,021235s009lbl.pdf
09/20/2006 SUPPL-76 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018936s076lbl.pdf
01/03/2003 SUPPL-64 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018936s064lbl.pdf
07/29/2002 SUPPL-61 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18936s61s65,20101s27,20974s1lbl.pdf
06/12/2002 SUPPL-67 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18936s67lbl.pdf
07/06/2000 SUPPL-58 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/18936S58LBL.PDF
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