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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019758
Company: HERITAGE LIFE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOZARIL CLOZAPINE 25MG TABLET;ORAL Prescription AB Yes No
CLOZARIL CLOZAPINE 100MG TABLET;ORAL Prescription AB Yes Yes
CLOZARIL CLOZAPINE 50MG TABLET;ORAL Prescription AB Yes No
CLOZARIL CLOZAPINE 200MG TABLET;ORAL Prescription AB Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/19/2022 SUPPL-101 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019758s101lbl.pdf
02/11/2021 SUPPL-88 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019758s088lbl.pdf
04/14/2020 SUPPL-95 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019758s095lbl.pdf
02/23/2017 SUPPL-84 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019758s084lbl.pdf
01/26/2017 SUPPL-81 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019758s081lbl.pdf
12/20/2016 SUPPL-80 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019758s080lbl.pdf
10/08/2015 SUPPL-78 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019758s078lbl.pdf
09/18/2015 SUPPL-74 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019758s074lbl.pdf
09/15/2015 SUPPL-77 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019758s061s077lbl.pdf
09/15/2015 SUPPL-61 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019758s061s077lbl.pdf
12/19/2014 SUPPL-73 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019758s073lbl.pdf
09/29/2014 SUPPL-72 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019758s072lbl.pdf
07/19/2013 SUPPL-71 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019758s069s071lbl.pdf
07/19/2013 SUPPL-69 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019758s069s071lbl.pdf
07/19/2013 SUPPL-69 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019758s069s071lbl.pdf
03/22/2013 SUPPL-70 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019758s067s068s070lbl.pdf
03/22/2013 SUPPL-68 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019758s067s068s070lbl.pdf
03/22/2013 SUPPL-67 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019758s067s068s070lbl.pdf
10/19/2011 SUPPL-63 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019758s063lbl.pdf
12/01/2010 SUPPL-65 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019758s065lbl.pdf
01/14/2010 SUPPL-62 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019758s062lbl.pdf
06/29/2005 SUPPL-56 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019758s056lbl.pdf
05/12/2005 SUPPL-54 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019758s054lbl.pdf
12/18/2002 SUPPL-47 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19758se1-047_Clozaril_lbl.pdf
01/14/2002 SUPPL-45 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19758s45lbl.pdf
08/29/2001 SUPPL-44 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19758s44lbl.pdf
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