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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020272
Company: JANSSEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RISPERDAL RISPERIDONE 1MG TABLET;ORAL Prescription AB Yes Yes
RISPERDAL RISPERIDONE 2MG TABLET;ORAL Prescription AB Yes No
RISPERDAL RISPERIDONE 3MG TABLET;ORAL Prescription AB Yes No
RISPERDAL RISPERIDONE 4MG TABLET;ORAL Prescription AB Yes No
RISPERDAL RISPERIDONE 5MG TABLET;ORAL Discontinued None No No
RISPERDAL RISPERIDONE 0.5MG TABLET;ORAL Prescription AB Yes No
RISPERDAL RISPERIDONE 0.25MG TABLET;ORAL Prescription AB Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/12/2021 SUPPL-83 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020272Orig1s083,020588Orig1s071,021444Orig1s057,021346Orig1s061lbl.pdf
02/05/2020 SUPPL-85 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020272s085,020588s072,021444s058lbl.pdf
01/25/2019 SUPPL-82 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020272s082,020588s070,021444s056lbl.pdf
07/27/2018 SUPPL-80 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020272s080,020588s068,021444s054lbl.pdf
02/23/2017 SUPPL-78 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020272s078,020588s066,021444s052lbl.pdf
03/01/2016 SUPPL-77 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020272s077,020588s065,021346s055,021444s051lbl.pdf
04/28/2014 SUPPL-73 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020272s073,020588s062,021444s048lbl.pdf
08/02/2012 SUPPL-65 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020272s065,020588s053,021444s041lbl.pdf
09/24/2011 SUPPL-66 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s060s066,020588s048s054,021444s035s042lbl.pdf
09/24/2011 SUPPL-60 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s060s066,020588s048s054,021444s035s042lbl.pdf
08/24/2011 SUPPL-59 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s059,020588s047,021444s034lbl.pdf
06/15/2011 SUPPL-64 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020272s064,020588s052,021444s040lbl.pdf
12/01/2010 SUPPL-63 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272s063,020588s051,021346s040,021444s039lbl.pdf
08/30/2010 SUPPL-62 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272S-055S-058S-061S-062lbl.pdf
08/30/2010 SUPPL-61 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272S-055S-058S-061S-062lbl.pdf
08/30/2010 SUPPL-58 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272S-055S-058S-061S-062lbl.pdf
08/30/2010 SUPPL-55 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272S-055S-058S-061S-062lbl.pdf
07/19/2009 SUPPL-56 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020272s056,020588s044,021346s033,021444s03lbl.pdf
08/22/2007 SUPPL-47 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020272s46s47,20588s36s37,21444s20s21lbl.pdf
08/22/2007 SUPPL-46 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020272s46s47,20588s36s37,21444s20s21lbl.pdf
10/06/2006 SUPPL-41 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021444s008s015,020588s024s028s029,020272s036s041lbl.pdf
10/06/2006 SUPPL-36 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021444s008s015,020588s024s028s029,020272s036s041lbl.pdf
08/17/2005 SUPPL-42 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020272s042,020588s030,021444s016,021346s010lbl.pdf
12/04/2003 SUPPL-27 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20272s-26,27,20588s-17,18,21444s-2,3_risperdal_lbl.pdf
12/04/2003 SUPPL-26 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20272s-26,27,20588s-17,18,21444s-2,3_risperdal_lbl.pdf
07/02/1999 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20588s05lbl.pdf
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