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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/29/2003 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21346ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21346_RisperdalTOC.html |
Supplements
| 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)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021346s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/021346Orig1s065,021444Orig1s060,020272Orig1s088,020588Orig1s074ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/021346Orig1s065.pdf | |
| 01/07/2021 | SUPPL-64 | Labeling-Package Insert |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021346Orig1s064ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/021346Orig1s064.pdf |
| 02/05/2020 | SUPPL-63 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021346s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020272Orig1s085, 020588Orig1s072, 021444Orig1s058, 021346Orig1s063ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/021346Orig1s063.pdf | |
| 11/22/2019 | SUPPL-62 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/021346Orig1s062.pdf | |
| 02/12/2021 | SUPPL-61 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020272Orig1s083,020588Orig1s071,021444Orig1s057,021346Orig1s061lbl.pdf#page=60 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020272Orig1s083, 020588Orig1s071, 021444Orig1s057, 021346Orig1s061ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/021346Orig1s061.pdf | |
| 01/25/2019 | SUPPL-60 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021346s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020272Orig1s082,020588Orig1s070,021444Orig1s056,021346Orig1s060Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/021346Orig1s060.pdf | |
| 04/12/2018 | SUPPL-59 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/021346Orig1s059.pdf | |
| 07/27/2018 | SUPPL-58 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021346s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020272Orig1s080,020588Orig1s068,021444Orig1s054,021346Orig1s058ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/021346Orig1s058.pdf | |
| 02/23/2017 | SUPPL-56 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021346s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020272Orig1s078,020588Orig1s066,021444Orig1s052,021346Orig1s056ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/021346Orig1s056.pdf | |
| 03/01/2016 | SUPPL-55 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020272s077,020588s065,021346s055,021444s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021346Orig1s055,022264Orig1s019,020272Orig1s077,021444Orig1s051,020588Orig1s065,021999Orig1s030,207946Orig1s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/021346Orig1s055.pdf | |
| 11/18/2016 | SUPPL-54 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/021346Orig1s054.pdf | |
| 06/05/2014 | SUPPL-52 | Manufacturing (CMC) |
Label (PDF)
Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021346s052Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021346Orig1s052.pdf | |
| 04/28/2014 | SUPPL-51 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021346s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020272Orig1s073,020588Orig1s062,021444Orig1s048,021346Orig1s051ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021346Orig1s051.pdf | |
| 10/22/2013 | SUPPL-50 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021346Orig1s050.pdf |
| 07/18/2013 | SUPPL-49 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021346Orig1s049.pdf |
| 02/26/2013 | SUPPL-48 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021346Orig1s048.pdf |
| 10/10/2013 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/12/2012 | SUPPL-44 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020272s067,020588s055,021444s043,021346s044ltr.pdf |
| 09/24/2011 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s037s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021346s037,s043ltr.pdf | |
| 06/15/2011 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s064,020588s052,021444s040,021346s042ltr.pdf | |
| 12/07/2011 | SUPPL-41 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s032s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021346s032,s041ltr.pdf | |
| 12/01/2010 | SUPPL-40 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272s063,020588s051,021346s040,021444s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020272s063,020588s051,021346s040,021444s039ltr.pdf | |
| 08/30/2010 | SUPPL-39 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021346_s31_s35_s38_s39lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021346s031,s035,s038,s039ltr.pdf | |
| 08/30/2010 | SUPPL-38 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021346_s31_s35_s38_s39lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021346s031,s035,s038,s039ltr.pdf | |
| 09/24/2011 | SUPPL-37 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s037s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021346s037,s043ltr.pdf | |
| 08/24/2011 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020272s059,020588s047,021444s034,021346s036ltr.pdf | |
| 08/30/2010 | SUPPL-35 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021346_s31_s35_s38_s39lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021346s031,s035,s038,s039ltr.pdf | |
| 07/19/2009 | SUPPL-33 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020272s056,020588s044,021346s033,021444s03lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020272s056,020588s044,021346s033,021444s031ltr.pdf | |
| 12/07/2011 | SUPPL-32 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s032s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021346s032,s041ltr.pdf | |
| 08/30/2010 | SUPPL-31 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021346_s31_s35_s38_s39lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021346s031,s035,s038,s039ltr.pdf | |
| 05/15/2009 | SUPPL-28 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021346s025s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021346s025,021346s028ltr.pdf | |
| 08/14/2008 | SUPPL-27 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020272s054,020588s042,021346s027,021444s029ltr.pdf |
| 10/08/2008 | SUPPL-26 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021346s021s022s023s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021346s021, s022, s023, s026ltr.pdf | |
| 05/15/2009 | SUPPL-25 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021346s025s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021346s025,021346s028ltr.pdf | |
| 10/08/2008 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021346s021s022s023s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021346s021, s022, s023, s026ltr.pdf | |
| 10/08/2008 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021346s021s022s023s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021346s021, s022, s023, s026ltr.pdf | |
| 10/08/2008 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021346s021s022s023s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021346s021, s022, s023, s026ltr.pdf | |
| 03/09/2007 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021346s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021346s020ltr.pdf | |
| 04/12/2007 | SUPPL-15 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021346s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021346s015ltr.pdf | |
| 09/20/2006 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021346s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021346s013ltr.pdf | |
| 07/31/2006 | SUPPL-11 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021346s011LTR.pdf |
| 08/17/2005 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020272s042,020588s030,021444s016,021346s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020272s042,020588s030,021444s016,021346s010ltr.pdf | |
| 10/20/2006 | SUPPL-9 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021346s009ltr.pdf |
| 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 |
RISPERDAL CONSTA
POWDER;INTRAMUSCULAR; 25MG/VIAL
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RISPERDAL CONSTA | RISPERIDONE | 25MG/VIAL | POWDER;INTRAMUSCULAR | Prescription | Yes | AB | 021346 | JANSSEN PHARMS |
| RISPERIDONE | RISPERIDONE | 25MG/VIAL | POWDER;INTRAMUSCULAR | Prescription | No | AB | 218586 | AMNEAL |
| RISPERIDONE | RISPERIDONE | 25MG/VIAL | POWDER;INTRAMUSCULAR | Prescription | No | AB | 211220 | NANOMI |
| RISPERIDONE | RISPERIDONE | 25MG/VIAL | POWDER;INTRAMUSCULAR | Prescription | No | AB | 214068 | TEVA PHARMS USA INC |
POWDER;INTRAMUSCULAR; 37.5MG/VIAL
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RISPERDAL CONSTA | RISPERIDONE | 37.5MG/VIAL | POWDER;INTRAMUSCULAR | Prescription | Yes | AB | 021346 | JANSSEN PHARMS |
| RISPERIDONE | RISPERIDONE | 37.5MG/VIAL | POWDER;INTRAMUSCULAR | Prescription | No | AB | 218586 | AMNEAL |
| RISPERIDONE | RISPERIDONE | 37.5MG/VIAL | POWDER;INTRAMUSCULAR | Prescription | No | AB | 211220 | NANOMI |
| RISPERIDONE | RISPERIDONE | 37.5MG/VIAL | POWDER;INTRAMUSCULAR | Prescription | No | AB | 214068 | TEVA PHARMS USA INC |
POWDER;INTRAMUSCULAR; 50MG/VIAL
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RISPERDAL CONSTA | RISPERIDONE | 50MG/VIAL | POWDER;INTRAMUSCULAR | Prescription | Yes | AB | 021346 | JANSSEN PHARMS |
| RISPERIDONE | RISPERIDONE | 50MG/VIAL | POWDER;INTRAMUSCULAR | Prescription | No | AB | 218586 | AMNEAL |
| RISPERIDONE | RISPERIDONE | 50MG/VIAL | POWDER;INTRAMUSCULAR | Prescription | No | AB | 211220 | NANOMI |
| RISPERIDONE | RISPERIDONE | 50MG/VIAL | POWDER;INTRAMUSCULAR | Prescription | No | AB | 214068 | TEVA PHARMS USA INC |
POWDER;INTRAMUSCULAR; 12.5MG/VIAL
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RISPERDAL CONSTA | RISPERIDONE | 12.5MG/VIAL | POWDER;INTRAMUSCULAR | Prescription | Yes | AB | 021346 | JANSSEN PHARMS |
| RISPERIDONE | RISPERIDONE | 12.5MG/VIAL | POWDER;INTRAMUSCULAR | Prescription | No | AB | 218586 | AMNEAL |
| RISPERIDONE | RISPERIDONE | 12.5MG/VIAL | POWDER;INTRAMUSCULAR | Prescription | No | AB | 214068 | TEVA PHARMS USA INC |