Application 020272
- Type
- NDA
- Sponsor
- JANSSEN PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RISPERDAL | RISPERIDONE | TABLET;ORAL | 1MG | Yes | Yes |
| 002 | RISPERDAL | RISPERIDONE | TABLET;ORAL | 2MG | Yes | No |
| 003 | RISPERDAL | RISPERIDONE | TABLET;ORAL | 3MG | Yes | No |
| 004 | RISPERDAL | RISPERIDONE | TABLET;ORAL | 4MG | Yes | No |
| 005 | RISPERDAL | RISPERIDONE | TABLET;ORAL | 5MG | No | No |
| 007 | RISPERDAL | RISPERIDONE | TABLET;ORAL | 0.5MG | Yes | No |
| 008 | RISPERDAL | RISPERIDONE | TABLET;ORAL | 0.25MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020272-001 | RISPERDAL | RISPERIDONE | 1MG | TABLET / ORAL | AB | RLD, RS | 1993-12-29 |
| N020272-002 | RISPERDAL | RISPERIDONE | 2MG | TABLET / ORAL | AB | RLD | 1993-12-29 |
| N020272-003 | RISPERDAL | RISPERIDONE | 3MG | TABLET / ORAL | AB | RLD | 1993-12-29 |
| N020272-004 | RISPERDAL | RISPERIDONE | 4MG | TABLET / ORAL | AB | RLD | 1993-12-29 |
| N020272-005 | RISPERDAL | RISPERIDONE | 5MG | TABLET / ORAL | 1993-12-29 | ||
| N020272-007 | RISPERDAL | RISPERIDONE | 0.5MG | TABLET / ORAL | AB | RLD | 1999-01-27 |
| N020272-008 | RISPERDAL | RISPERIDONE | 0.25MG | TABLET / ORAL | AB | RLD | 1999-05-10 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N020272-001 | AB |
| N020272-002 | AB |
| N020272-003 | AB |
| N020272-004 | AB |
| N020272-007 | AB |
| N020272-008 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N020272-001 | RISPERDAL | 1MG | TABLET / ORAL | AB | RLD, RS | 1993-12-29 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020272-002 | RISPERDAL | 2MG | TABLET / ORAL | AB | RLD | 1993-12-29 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020272-003 | RISPERDAL | 3MG | TABLET / ORAL | AB | RLD | 1993-12-29 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020272-004 | RISPERDAL | 4MG | TABLET / ORAL | AB | RLD | 1993-12-29 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020272-005 | RISPERDAL | 5MG | TABLET / ORAL | 1993-12-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020272-007 | RISPERDAL | 0.5MG | TABLET / ORAL | AB | RLD | 1999-01-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020272-008 | RISPERDAL | 0.25MG | TABLET / ORAL | AB | RLD | 1999-05-10 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020272-001 | RISPERDAL | 1MG | TABLET / ORAL | AB | RLD, RS | 1993-12-29 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020272-002 | RISPERDAL | 2MG | TABLET / ORAL | AB | RLD | 1993-12-29 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020272-003 | RISPERDAL | 3MG | TABLET / ORAL | AB | RLD | 1993-12-29 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020272-004 | RISPERDAL | 4MG | TABLET / ORAL | AB | RLD | 1993-12-29 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020272-005 | RISPERDAL | 5MG | TABLET / ORAL | 1993-12-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020272-007 | RISPERDAL | 0.5MG | TABLET / ORAL | AB | RLD | 1999-01-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020272-008 | RISPERDAL | 0.25MG | TABLET / ORAL | AB | RLD | 1999-05-10 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020272-001 | RISPERDAL | 1MG | TABLET / ORAL | AB | RLD, RS | 1993-12-29 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020272-002 | RISPERDAL | 2MG | TABLET / ORAL | AB | RLD | 1993-12-29 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020272-003 | RISPERDAL | 3MG | TABLET / ORAL | AB | RLD | 1993-12-29 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020272-004 | RISPERDAL | 4MG | TABLET / ORAL | AB | RLD | 1993-12-29 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020272-005 | RISPERDAL | 5MG | TABLET / ORAL | 1993-12-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020272-007 | RISPERDAL | 0.5MG | TABLET / ORAL | AB | RLD | 1999-01-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020272-008 | RISPERDAL | 0.25MG | TABLET / ORAL | AB | RLD | 1999-05-10 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020272-001 | RISPERDAL | 1MG | TABLET / ORAL | AB | RLD, RS | 1993-12-29 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020272-002 | RISPERDAL | 2MG | TABLET / ORAL | AB | RLD | 1993-12-29 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020272-003 | RISPERDAL | 3MG | TABLET / ORAL | AB | RLD | 1993-12-29 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020272-004 | RISPERDAL | 4MG | TABLET / ORAL | AB | RLD | 1993-12-29 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020272-005 | RISPERDAL | 5MG | TABLET / ORAL | 1993-12-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020272-007 | RISPERDAL | 0.5MG | TABLET / ORAL | AB | RLD | 1999-01-27 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020272-008 | RISPERDAL | 0.25MG | TABLET / ORAL | AB | RLD | 1999-05-10 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020272-001 | RISPERDAL | 1MG | TABLET / ORAL | AB | RLD, RS | 1993-12-29 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020272-002 | RISPERDAL | 2MG | TABLET / ORAL | AB | RLD | 1993-12-29 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020272-003 | RISPERDAL | 3MG | TABLET / ORAL | AB | RLD | 1993-12-29 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020272-004 | RISPERDAL | 4MG | TABLET / ORAL | AB | RLD | 1993-12-29 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020272-005 | RISPERDAL | 5MG | TABLET / ORAL | 1993-12-29 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020272-007 | RISPERDAL | 0.5MG | TABLET / ORAL | AB | RLD | 1999-01-27 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020272-008 | RISPERDAL | 0.25MG | TABLET / ORAL | AB | RLD | 1999-05-10 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020272-001 | RISPERDAL | 1MG | TABLET / ORAL | AB | RLD, RS | 1993-12-29 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020272-002 | RISPERDAL | 2MG | TABLET / ORAL | AB | RLD | 1993-12-29 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020272-003 | RISPERDAL | 3MG | TABLET / ORAL | AB | RLD | 1993-12-29 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020272-004 | RISPERDAL | 4MG | TABLET / ORAL | AB | RLD | 1993-12-29 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020272-005 | RISPERDAL | 5MG | TABLET / ORAL | 1993-12-29 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N020272-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020272-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020272-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020272-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020272-007 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020272-008 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020272-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020272-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020272-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020272-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020272-007 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020272-008 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020272-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020272-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020272-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020272-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020272-007 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020272-008 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020272-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020272-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020272-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020272-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020272-007 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020272-008 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020272-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020272-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020272-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020272-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020272-007 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020272-008 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020272-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020272-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020272-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020272-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020272-007 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020272-008 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020272-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020272-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020272-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020272-004 | AB | 1 | 2680178bc6a6… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Risperidone | RISPERIDONE | Janssen Pharmaceutical, Inc. | 701e1cd8-2868-4d29-85a9-a2212c88165f | 2026-06-12 | Boxed warning, Warnings, Adverse reactions | 50458-591 50458-593 50458-592 |
| RISPERDAL | RISPERIDONE | Janssen Pharmaceuticals, Inc. | 7e117c7e-02fc-4343-92a1-230061dfc5e0 | 2026-05-28 | Boxed warning, Warnings, Adverse reactions | 020272 NDA020272 50458-302 50458-320 50458-330 50458-300 50458-350 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 21695-113 | RISPERDAL | risperidone | Rebel Distributors Corp | NDA | Current |
| 21695-115 | RISPERDAL | risperidone | Rebel Distributors Corp | NDA | Current |
| 43353-412 | Risperidone | risperidone | Aphena Pharma Solutions - Tennessee, LLC | NDA | Current |
| 43353-432 | Risperidone | risperidone | Aphena Pharma Solutions - Tennessee, LLC | NDA | Current |
| 43353-720 | Risperidone | risperidone | Aphena Pharma Solutions - Tennessee, LLC | NDA | Current |
| 50458-300 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-300 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-300 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-300 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-300 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-300 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-300 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-300 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-300 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-300 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-300 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-301 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-301 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-301 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-301 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-301 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-301 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-301 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-301 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-301 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-302 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-302 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-302 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-302 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-302 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-302 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-302 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-302 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-302 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-302 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-302 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-320 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-320 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-320 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-320 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-320 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-320 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-320 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-320 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-320 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-320 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-320 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-330 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-330 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-330 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-330 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-330 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-330 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-330 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-330 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-330 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-330 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-330 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-350 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-350 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-350 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-350 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-350 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-350 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-350 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-350 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-350 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-350 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-350 | RISPERDAL | risperidone | Janssen Pharmaceuticals, Inc. | NDA | Current |
| 50458-590 | Risperidone | risperidone | Janssen Pharmaceutical, Inc. | NDA | Current |
| 50458-590 | Risperidone | risperidone | Janssen Pharmaceutical, Inc. | NDA | Current |
| 50458-590 | Risperidone | risperidone | Janssen Pharmaceutical, Inc. | NDA | Current |
| 50458-591 | Risperidone | risperidone | Janssen Pharmaceutical, Inc. | NDA | Current |
| 50458-591 | Risperidone | risperidone | Janssen Pharmaceutical, Inc. | NDA | Current |
| 50458-591 | Risperidone | risperidone | Janssen Pharmaceutical, Inc. | NDA | Current |
| 50458-592 | Risperidone | risperidone | Janssen Pharmaceutical, Inc. | NDA | Current |
| 50458-592 | Risperidone | risperidone | Janssen Pharmaceutical, Inc. | NDA | Current |
| 50458-592 | Risperidone | risperidone | Janssen Pharmaceutical, Inc. | NDA | Current |
| 50458-593 | Risperidone | risperidone | Janssen Pharmaceutical, Inc. | NDA | Current |
| 50458-593 | Risperidone | risperidone | Janssen Pharmaceutical, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83887 | SUPPL | 2025-10-23 |
| 83886 | SUPPL | 2025-10-23 |
| 81130 | SUPPL | 2025-02-07 |
| 81030 | SUPPL | 2025-02-05 |
| 72791 | SUPPL | 2022-12-05 |
| 72783 | SUPPL | 2022-12-05 |
| 66281 | SUPPL | 2021-02-18 |
| 66239 | SUPPL | 2021-02-17 |
| 61842 | SUPPL | 2020-02-07 |
| 61785 | SUPPL | 2020-02-06 |
| 57553 | SUPPL | 2019-02-13 |
| 57360 | SUPPL | 2019-01-28 |
| 55144 | SUPPL | 2018-08-09 |
| 55050 | SUPPL | 2018-07-30 |
| 47420 | SUPPL | 2017-03-02 |
| 47320 | SUPPL | 2017-02-24 |
| 34460 | SUPPL | 2016-03-03 |
| 24714 | SUPPL | 2016-03-03 |
| 24713 | SUPPL | 2014-05-09 |
| 34459 | SUPPL | 2014-04-29 |
| 41261 | SUPPL | 2013-06-03 |
| 41260 | SUPPL | 2013-06-03 |
| 24710 | SUPPL | 2012-08-03 |
| 12408 | SUPPL | 2012-08-03 |
| 24712 | SUPPL | 2012-03-13 |
| 44053 | ORIG | 2011-12-20 |
| 41262 | SUPPL | 2011-12-14 |
| 20581 | SUPPL | 2011-12-14 |
| 34458 | SUPPL | 2011-09-30 |
| 34455 | SUPPL | 2011-09-30 |
| 24711 | SUPPL | 2011-09-28 |
| 24707 | SUPPL | 2011-09-28 |
| 24706 | SUPPL | 2011-08-26 |
| 12405 | SUPPL | 2011-08-25 |
| 24709 | SUPPL | 2011-06-17 |
| 12407 | SUPPL | 2011-06-16 |
| 41255 | ORIG | 2011-02-15 |
| 2282 | SUPPL | 2010-12-06 |
| 12406 | SUPPL | 2010-12-04 |
| 24708 | SUPPL | 2010-09-07 |
| 24705 | SUPPL | 2010-09-07 |
| 2281 | SUPPL | 2010-09-07 |
| 2279 | SUPPL | 2010-09-07 |
| 34457 | SUPPL | 2010-08-30 |
| 34456 | SUPPL | 2010-08-30 |
| 12404 | SUPPL | 2010-08-30 |
| 12402 | SUPPL | 2010-08-30 |
| 41259 | SUPPL | 2009-09-16 |
| 20579 | SUPPL | 2009-09-16 |
| 12403 | SUPPL | 2009-08-06 |
| 2280 | SUPPL | 2009-08-06 |
| 41258 | SUPPL | 2009-01-12 |
| 2278 | SUPPL | 2008-08-19 |
| 20580 | SUPPL | 2008-02-19 |
| 12401 | SUPPL | 2007-08-23 |
| 12400 | SUPPL | 2007-08-23 |
| 24704 | SUPPL | 2007-08-22 |
| 2277 | SUPPL | 2007-08-22 |
| 41256 | SUPPL | 2007-07-20 |
| 20578 | SUPPL | 2007-07-20 |
| 24702 | SUPPL | 2006-10-18 |
| 24701 | SUPPL | 2006-10-18 |
| 12398 | SUPPL | 2006-10-11 |
| 12397 | SUPPL | 2006-10-11 |
| 24703 | SUPPL | 2005-08-19 |
| 12399 | SUPPL | 2005-08-19 |
| 23969 | SUPPL | 2004-11-03 |
| 24700 | SUPPL | 2004-06-16 |
| 12395 | SUPPL | 2004-06-16 |
| 2273 | SUPPL | 2004-06-16 |
| 34454 | SUPPL | 2003-12-11 |
| 24699 | SUPPL | 2003-12-11 |
| 12396 | SUPPL | 2003-12-11 |
| 2275 | SUPPL | 2003-12-11 |
| 24698 | SUPPL | 2003-11-28 |
| 2276 | SUPPL | 2003-11-25 |
| 2274 | SUPPL | 2002-11-19 |
| 24697 | SUPPL | 2002-03-03 |
| 41257 | SUPPL | 1997-10-17 |
| 52165 | SUPPL | 1900-01-01 |
| 52164 | SUPPL | 1900-01-01 |
| 52163 | SUPPL | 1900-01-01 |
| 52162 | SUPPL | 1900-01-01 |
| 52161 | SUPPL | 1900-01-01 |
| 51647 | ORIG | 1900-01-01 |
| 51646 | ORIG | 1900-01-01 |
| 51645 | ORIG | 1900-01-01 |
| 51644 | ORIG | 1900-01-01 |
| 51643 | ORIG | 1900-01-01 |