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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021427
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYMBALTA DULOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription AB Yes No
CYMBALTA DULOXETINE HYDROCHLORIDE EQ 30MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription AB Yes No
CYMBALTA DULOXETINE HYDROCHLORIDE EQ 60MG BASE CAPSULE, DELAYED REL PELLETS;ORAL Prescription AB Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/20/2021 SUPPL-56 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021427s056lbl.pdf
10/01/2020 SUPPL-53 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021427s053lbl.pdf
04/20/2020 SUPPL-52 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021427s052lbl.pdf
10/04/2019 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021427s051lbl.pdf
12/19/2017 SUPPL-50 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021427s050lbl.pdf
01/04/2017 SUPPL-49 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021427s049lbl.pdf
09/02/2016 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021427s048lbl.pdf
06/18/2015 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021427s046lbl.pdf
11/25/2014 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021427s037s042lbl.pdf
11/25/2014 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021427s037s042lbl.pdf
10/16/2014 SUPPL-44 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021427s043s044lbl.pdf
10/16/2014 SUPPL-43 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021427s043s044lbl.pdf
07/17/2014 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021427Orig1s045lbl.pdf
10/18/2012 SUPPL-41 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021427s040s041lbl.pdf
10/18/2012 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021427s040s041lbl.pdf
10/18/2012 SUPPL-40 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021427s040s041lbl.pdf
08/24/2012 SUPPL-38 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021427s032s038lbl.pdf
08/24/2012 SUPPL-32 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021427s032s038lbl.pdf
09/02/2011 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021427s039lbl.pdf
04/12/2011 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021427s036lbl.pdf
03/04/2011 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021427s031lbl.pdf
11/19/2009 SUPPL-30 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021427s030lbl.pdf
03/18/2009 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021427s021s027s028lbl.pdf
03/18/2009 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021427s021s027s028lbl.pdf
03/18/2009 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021427s021s027s028lbl.pdf
01/30/2009 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021427s029lbl.pdf
11/28/2007 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021427s015s017lbl.pdf
11/28/2007 SUPPL-15 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021427s015s017lbl.pdf
08/02/2007 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021427s018lbl.pdf
02/23/2007 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021427s009s011s013lbl.pdf
02/23/2007 SUPPL-11 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021427s009s011s013lbl.pdf
02/23/2007 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021427s009s011s013lbl.pdf
09/20/2006 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021427s012lbl.pdf
08/03/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21427lbl.pdf
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