Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021476
Company: SUNOVION PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LUNESTA ESZOPICLONE 1MG TABLET;ORAL Prescription AB Yes No
LUNESTA ESZOPICLONE 2MG TABLET;ORAL Prescription AB Yes No
LUNESTA ESZOPICLONE 3MG TABLET;ORAL Prescription AB Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/18/2019 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021476Orig1s038rplLBL.pdf
02/06/2019 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021476s037lbl.pdf
11/07/2018 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021476s036lbl.pdf
05/15/2014 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021476s030lbl.pdf
02/03/2014 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021476s028lbl.pdf
10/10/2012 SUPPL-26 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021476s024s026lbl.pdf
10/10/2012 SUPPL-24 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021476s024s026lbl.pdf
10/10/2012 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021476s024s026lbl.pdf
04/06/2009 SUPPL-12 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021476s012lbl.pdf
01/29/2008 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021476s005s008lbl.pdf
01/29/2008 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021476s005s008lbl.pdf
12/15/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021476lbl.pdf

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