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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020825
Company: VIATRIS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GEODON ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription AB Yes Yes
GEODON ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Prescription AB Yes No
GEODON ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE;ORAL Prescription AB Yes No
GEODON ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE;ORAL Prescription AB Yes No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
01/28/2022 SUPPL-63 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020825s063lbl.pdf
05/18/2021 SUPPL-62 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020825s062,020919s050lbl.pdf
10/29/2020 SUPPL-61 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020825Orig1s061,020919Orig1s049lbl.pdf
01/23/2020 SUPPL-58 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020825s058,020919s045lbl.pdf
11/05/2018 SUPPL-59 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020825s059,020919s047lbl.pdf
02/23/2017 SUPPL-56 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020825s056,020919s044,021483s015lbl.pdf
02/23/2017 SUPPL-56 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020825s056,020919s044,021483s015lbl.pdf
08/20/2015 SUPPL-54 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020825s054,020919s041,021483s014lbl.pdf
12/10/2014 SUPPL-53 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020825s053,020919s040,s021483s013lbl.pdf
12/17/2013 SUPPL-49 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s049,020919s035lbl.pdf
08/13/2013 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s047,020919s032,021483s010lbl.pdf
07/03/2013 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s041,020919s027,021483s007lbl.pdf
03/01/2013 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s046,020919s030,021483s009lbl.pdf
12/01/2010 SUPPL-38 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020825s038,020919s025,021483s005lbl.pdf
11/20/2009 SUPPL-34 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020825s034lbl.pdf
07/19/2009 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020825s035,020919s023lbl.pdf
10/02/2007 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020825s026,020919s016lbl.pdf
05/24/2007 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020825s024,020919s014lbl.pdf
03/02/2007 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020825s021,020919s012lbl.pdf
08/17/2005 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020825s015,017,020919s005,006lbl.pdf
08/17/2005 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020825s015,017,020919s005,006lbl.pdf
08/19/2004 SUPPL-9 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020825s009lbl.pdf
02/05/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20825lbl.pdf
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