Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021346
Company: JANSSEN PHARMS
Company: JANSSEN PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RISPERDAL CONSTA | RISPERIDONE | 25MG/VIAL | POWDER;INTRAMUSCULAR | Prescription | AB | Yes | Yes |
| RISPERDAL CONSTA | RISPERIDONE | 37.5MG/VIAL | POWDER;INTRAMUSCULAR | Prescription | AB | Yes | Yes |
| RISPERDAL CONSTA | RISPERIDONE | 50MG/VIAL | POWDER;INTRAMUSCULAR | Prescription | AB | Yes | Yes |
| RISPERDAL CONSTA | RISPERIDONE | 12.5MG/VIAL | POWDER;INTRAMUSCULAR | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/22/2025 | SUPPL-65 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021346s065lbl.pdf | |
| 02/12/2021 | SUPPL-61 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020272Orig1s083,020588Orig1s071,021444Orig1s057,021346Orig1s061lbl.pdf#page=60 | |
| 02/05/2020 | SUPPL-63 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021346s063lbl.pdf | |
| 01/25/2019 | SUPPL-60 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021346s060lbl.pdf | |
| 07/27/2018 | SUPPL-58 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021346s058lbl.pdf | |
| 02/23/2017 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021346s056lbl.pdf | |
| 03/01/2016 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020272s077,020588s065,021346s055,021444s051lbl.pdf | |
| 06/05/2014 | SUPPL-52 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021346s052Lbl.pdf |
| 04/28/2014 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021346s051lbl.pdf | |
| 12/07/2011 | SUPPL-41 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s032s041lbl.pdf | |
| 12/07/2011 | SUPPL-32 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s032s041lbl.pdf | |
| 09/24/2011 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s037s043lbl.pdf | |
| 09/24/2011 | SUPPL-37 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s037s043lbl.pdf | |
| 08/24/2011 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s036lbl.pdf | |
| 06/15/2011 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s042lbl.pdf | |
| 12/01/2010 | SUPPL-40 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272s063,020588s051,021346s040,021444s039lbl.pdf | |
| 08/30/2010 | SUPPL-39 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021346_s31_s35_s38_s39lbl.pdf | |
| 08/30/2010 | SUPPL-38 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021346_s31_s35_s38_s39lbl.pdf | |
| 08/30/2010 | SUPPL-35 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021346_s31_s35_s38_s39lbl.pdf | |
| 08/30/2010 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021346_s31_s35_s38_s39lbl.pdf | |
| 07/19/2009 | SUPPL-33 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020272s056,020588s044,021346s033,021444s03lbl.pdf | |
| 05/15/2009 | SUPPL-28 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021346s025s028lbl.pdf | |
| 05/15/2009 | SUPPL-25 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021346s025s028lbl.pdf | |
| 10/08/2008 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021346s021s022s023s026lbl.pdf | |
| 10/08/2008 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021346s021s022s023s026lbl.pdf | |
| 10/08/2008 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021346s021s022s023s026lbl.pdf | |
| 10/08/2008 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021346s021s022s023s026lbl.pdf | |
| 04/12/2007 | SUPPL-15 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021346s015lbl.pdf | |
| 03/09/2007 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021346s020lbl.pdf | |
| 09/20/2006 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021346s013lbl.pdf | |
| 08/17/2005 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020272s042,020588s030,021444s016,021346s010lbl.pdf |