Application 021346
- Type
- NDA
- Sponsor
- JANSSEN PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RISPERDAL CONSTA | RISPERIDONE | INJECTABLE;INTRAMUSCULAR | 25MG/VIAL | Yes | Yes |
| 002 | RISPERDAL CONSTA | RISPERIDONE | INJECTABLE;INTRAMUSCULAR | 37.5MG/VIAL | Yes | No |
| 003 | RISPERDAL CONSTA | RISPERIDONE | INJECTABLE;INTRAMUSCULAR | 50MG/VIAL | Yes | No |
| 004 | RISPERDAL CONSTA | RISPERIDONE | INJECTABLE;INTRAMUSCULAR | 12.5MG/VIAL | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50458-306 | RISPERDAL CONSTA | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-306 | RISPERDAL CONSTA | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-306 | RISPERDAL CONSTA | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-306 | RISPERDAL CONSTA | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-306 | RISPERDAL CONSTA | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-307 | RISPERDAL CONSTA | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-307 | RISPERDAL CONSTA | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-307 | RISPERDAL CONSTA | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-307 | RISPERDAL CONSTA | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-307 | RISPERDAL CONSTA | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-308 | RISPERDAL CONSTA | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-308 | RISPERDAL CONSTA | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-308 | RISPERDAL CONSTA | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-308 | RISPERDAL CONSTA | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-308 | RISPERDAL CONSTA | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-309 | RISPERDAL CONSTA | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-309 | RISPERDAL CONSTA | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-309 | RISPERDAL CONSTA | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-309 | RISPERDAL CONSTA | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-309 | RISPERDAL CONSTA | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83889 | SUPPL | 2025-10-23 |
| 81128 | SUPPL | 2025-02-07 |
| 81029 | SUPPL | 2025-02-05 |
| 71934 | SUPPL | 2022-08-26 |
| 71933 | SUPPL | 2022-08-26 |
| 71921 | SUPPL | 2022-08-26 |
| 71919 | SUPPL | 2022-08-26 |
| 71917 | SUPPL | 2022-08-26 |
| 71916 | SUPPL | 2022-08-26 |
| 71914 | SUPPL | 2022-08-26 |
| 71912 | SUPPL | 2022-08-26 |
| 71910 | SUPPL | 2022-08-26 |
| 71909 | SUPPL | 2022-08-26 |
| 71907 | SUPPL | 2022-08-26 |
| 71905 | SUPPL | 2022-08-26 |
| 71902 | SUPPL | 2022-08-26 |
| 71897 | SUPPL | 2022-08-26 |
| 71895 | SUPPL | 2022-08-26 |
| 66280 | SUPPL | 2021-02-18 |
| 66242 | SUPPL | 2021-02-17 |
| 65868 | SUPPL | 2021-01-08 |
| 61843 | SUPPL | 2020-02-07 |
| 61788 | SUPPL | 2020-02-06 |
| 57556 | SUPPL | 2019-02-13 |
| 57363 | SUPPL | 2019-01-28 |
| 55147 | SUPPL | 2018-08-09 |
| 55053 | SUPPL | 2018-07-30 |
| 47423 | SUPPL | 2017-03-02 |
| 47321 | SUPPL | 2017-02-24 |
| 36722 | SUPPL | 2016-03-03 |
| 27558 | SUPPL | 2016-03-03 |
| 36721 | SUPPL | 2014-06-10 |
| 27557 | SUPPL | 2014-05-09 |
| 15253 | SUPPL | 2014-04-29 |
| 27556 | SUPPL | 2012-03-13 |
| 23648 | ORIG | 2011-12-20 |
| 27555 | SUPPL | 2011-12-13 |
| 15250 | SUPPL | 2011-12-13 |
| 15246 | SUPPL | 2011-12-13 |
| 5116 | SUPPL | 2011-12-13 |
| 36719 | SUPPL | 2011-09-30 |
| 15252 | SUPPL | 2011-09-30 |
| 27552 | SUPPL | 2011-09-28 |
| 5121 | SUPPL | 2011-09-28 |
| 36718 | SUPPL | 2011-09-02 |
| 27551 | SUPPL | 2011-08-26 |
| 5120 | SUPPL | 2011-06-17 |
| 15251 | SUPPL | 2011-06-16 |
| 5119 | SUPPL | 2010-12-06 |
| 15249 | SUPPL | 2010-12-04 |
| 27554 | SUPPL | 2010-09-01 |
| 27553 | SUPPL | 2010-09-01 |
| 27550 | SUPPL | 2010-09-01 |
| 5118 | SUPPL | 2010-09-01 |
| 36720 | SUPPL | 2010-08-30 |
| 36717 | SUPPL | 2010-08-30 |
| 15248 | SUPPL | 2010-08-30 |
| 15245 | SUPPL | 2010-08-30 |
| 15247 | SUPPL | 2009-08-06 |
| 5117 | SUPPL | 2009-08-06 |
| 36716 | SUPPL | 2009-06-07 |
| 36714 | SUPPL | 2009-06-07 |
| 5115 | SUPPL | 2009-05-20 |
| 5113 | SUPPL | 2009-05-20 |
| 36715 | SUPPL | 2008-11-07 |
| 36713 | SUPPL | 2008-11-07 |
| 36712 | SUPPL | 2008-11-07 |
| 15244 | SUPPL | 2008-11-07 |
| 27548 | SUPPL | 2008-10-14 |
| 5114 | SUPPL | 2008-10-14 |
| 5112 | SUPPL | 2008-10-14 |
| 5111 | SUPPL | 2008-10-14 |
| 27549 | SUPPL | 2008-08-19 |
| 36711 | SUPPL | 2007-04-20 |
| 27547 | SUPPL | 2007-04-20 |
| 15243 | SUPPL | 2007-03-15 |
| 5110 | SUPPL | 2007-03-15 |
| 5109 | SUPPL | 2006-10-23 |
| 27546 | SUPPL | 2006-09-25 |
| 15242 | SUPPL | 2006-09-21 |
| 27545 | SUPPL | 2006-08-04 |
| 27544 | SUPPL | 2005-08-19 |
| 15241 | SUPPL | 2005-08-19 |
| 21611 | ORIG | 2005-06-16 |
| 27543 | ORIG | 2003-11-28 |