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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016608
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TEGRETOL CARBAMAZEPINE 200MG TABLET;ORAL Prescription AB Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/20/2018 SUPPL-116 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016608s115_018281_s058_018927s055_020234_s047.pdf
08/28/2015 SUPPL-97 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016608s097,018281s045,018927s038,020234s026lbl.pdf
09/16/2014 SUPPL-99 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s099,018281s047,018927s040,020234s030lbl.pdf
01/16/2014 SUPPL-103 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016608s103,018281s051,018927s044,020234s035lbl.pdf
03/06/2013 SUPPL-105 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016608s105,018281s053,018927s046,020234s038lbl.pdf
12/11/2012 SUPPL-107 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016608s107,018281s055,018927s048,020234s040lbl.pdf
03/03/2011 SUPPL-102 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf
03/03/2011 SUPPL-100 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf
03/03/2011 SUPPL-100 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf
04/23/2009 SUPPL-101 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016608s101,018281s048lbl.pdf
12/11/2007 SUPPL-98 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016608s098lbl.pdf
08/16/2007 SUPPL-96 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016608s096,018281s044,018927s035,020234s025REVISED_LABEL.pdf
03/07/2001 SUPPL-90 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20234S17LBL.PDF
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