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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020789
Company: CONCORDIA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZONEGRAN ZONISAMIDE 100MG CAPSULE;ORAL Prescription AB Yes Yes
ZONEGRAN ZONISAMIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE;ORAL Discontinued None Yes No
ZONEGRAN ZONISAMIDE 25MG CAPSULE;ORAL Prescription AB Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/13/2020 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020789s036lbl.pdf
04/06/2016 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020789s034lbl.pdf
06/19/2015 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020789s021lbl.pdf
01/26/2012 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020789s012lbl.pdf
09/23/2011 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020789s030lbl.pdf
09/23/2011 SUPPL-30 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020789s030lbl.pdf
04/19/2010 SUPPL-26 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020789s024lbl.pdf
04/19/2010 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020789s024lbl.pdf
04/19/2010 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020789s024lbl.pdf
04/23/2009 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020789s022s025lbl.pdf
04/23/2009 SUPPL-25 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020789s022s025lbl.pdf
04/23/2009 SUPPL-22 REMS Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020789s022s025lbl.pdf
11/20/2006 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020789s019lbl.pdf
08/22/2003 SUPPL-1 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20789scm001_zonegran_lbl.pdf
10/07/2002 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20789s5lbl.pdf
03/27/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20789lbl.pdf
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