Application 201003
- Type
- ANDA
- Sponsor
- AJANTA PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RISPERIDONE | RISPERIDONE | TABLET;ORAL | 0.25MG | No | No |
| 002 | RISPERIDONE | RISPERIDONE | TABLET;ORAL | 0.5MG | No | No |
| 003 | RISPERIDONE | RISPERIDONE | TABLET;ORAL | 1MG | No | No |
| 004 | RISPERIDONE | RISPERIDONE | TABLET;ORAL | 2MG | No | No |
| 005 | RISPERIDONE | RISPERIDONE | TABLET;ORAL | 3MG | No | No |
| 006 | RISPERIDONE | RISPERIDONE | TABLET;ORAL | 4MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A201003-001 | RISPERIDONE | RISPERIDONE | 0.25MG | TABLET / ORAL | AB | 2011-08-24 | |
| A201003-002 | RISPERIDONE | RISPERIDONE | 0.5MG | TABLET / ORAL | AB | 2011-08-24 | |
| A201003-003 | RISPERIDONE | RISPERIDONE | 1MG | TABLET / ORAL | AB | 2011-08-24 | |
| A201003-004 | RISPERIDONE | RISPERIDONE | 2MG | TABLET / ORAL | AB | 2011-08-24 | |
| A201003-005 | RISPERIDONE | RISPERIDONE | 3MG | TABLET / ORAL | AB | 2011-08-24 | |
| A201003-006 | RISPERIDONE | RISPERIDONE | 4MG | TABLET / ORAL | AB | 2011-08-24 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A201003-001 | AB |
| A201003-002 | AB |
| A201003-003 | AB |
| A201003-004 | AB |
| A201003-005 | AB |
| A201003-006 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A201003-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | AB | 2011-08-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A201003-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | AB | 2011-08-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A201003-003 | RISPERIDONE | 1MG | TABLET / ORAL | AB | 2011-08-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A201003-004 | RISPERIDONE | 2MG | TABLET / ORAL | AB | 2011-08-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A201003-005 | RISPERIDONE | 3MG | TABLET / ORAL | AB | 2011-08-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A201003-006 | RISPERIDONE | 4MG | TABLET / ORAL | AB | 2011-08-24 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A201003-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | AB | 2011-08-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A201003-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | AB | 2011-08-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A201003-003 | RISPERIDONE | 1MG | TABLET / ORAL | AB | 2011-08-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A201003-004 | RISPERIDONE | 2MG | TABLET / ORAL | AB | 2011-08-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A201003-005 | RISPERIDONE | 3MG | TABLET / ORAL | AB | 2011-08-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A201003-006 | RISPERIDONE | 4MG | TABLET / ORAL | AB | 2011-08-24 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201003-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | AB | 2011-08-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201003-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | AB | 2011-08-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201003-003 | RISPERIDONE | 1MG | TABLET / ORAL | AB | 2011-08-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201003-004 | RISPERIDONE | 2MG | TABLET / ORAL | AB | 2011-08-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201003-005 | RISPERIDONE | 3MG | TABLET / ORAL | AB | 2011-08-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201003-006 | RISPERIDONE | 4MG | TABLET / ORAL | AB | 2011-08-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201003-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | AB | 2011-08-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201003-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | AB | 2011-08-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201003-003 | RISPERIDONE | 1MG | TABLET / ORAL | AB | 2011-08-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201003-004 | RISPERIDONE | 2MG | TABLET / ORAL | AB | 2011-08-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201003-005 | RISPERIDONE | 3MG | TABLET / ORAL | AB | 2011-08-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201003-006 | RISPERIDONE | 4MG | TABLET / ORAL | AB | 2011-08-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201003-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | AB | 2011-08-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201003-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | AB | 2011-08-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201003-003 | RISPERIDONE | 1MG | TABLET / ORAL | AB | 2011-08-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201003-004 | RISPERIDONE | 2MG | TABLET / ORAL | AB | 2011-08-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201003-005 | RISPERIDONE | 3MG | TABLET / ORAL | AB | 2011-08-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201003-006 | RISPERIDONE | 4MG | TABLET / ORAL | AB | 2011-08-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201003-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | AB | 2011-08-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201003-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | AB | 2011-08-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201003-003 | RISPERIDONE | 1MG | TABLET / ORAL | AB | 2011-08-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201003-004 | RISPERIDONE | 2MG | TABLET / ORAL | AB | 2011-08-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201003-005 | RISPERIDONE | 3MG | TABLET / ORAL | AB | 2011-08-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201003-006 | RISPERIDONE | 4MG | TABLET / ORAL | AB | 2011-08-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201003-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | AB | 2011-08-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201003-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | AB | 2011-08-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201003-003 | RISPERIDONE | 1MG | TABLET / ORAL | AB | 2011-08-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201003-004 | RISPERIDONE | 2MG | TABLET / ORAL | AB | 2011-08-24 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A201003-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A201003-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A201003-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A201003-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A201003-005 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A201003-006 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A201003-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A201003-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A201003-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A201003-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A201003-005 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A201003-006 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A201003-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201003-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201003-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201003-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201003-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201003-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201003-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201003-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201003-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201003-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201003-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201003-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A201003-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201003-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201003-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201003-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201003-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201003-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201003-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201003-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201003-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201003-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201003-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201003-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201003-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201003-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201003-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201003-004 | AB | 1 | b8a1b40f171c… |
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 | Proficient Rx LP | 2b9cce47-b8b3-4c9b-b26a-3d742a0db8e2 | 2022-10-01 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 63187-439 |
| RISPERIDONE | RISPERIDONE | Proficient Rx LP | 088dc3dd-7740-471b-8c06-5a47900ae5b5 | 2022-10-01 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 63187-264 |
| RISPERIDONE | RISPERIDONE | Proficient Rx LP | 1b5c9889-4dc3-48df-8629-4ac099e2b4c0 | 2022-10-01 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 63187-642 |
| RISPERIDONE | RISPERIDONE | Proficient Rx LP | 394c7e27-52a2-4d4c-8c6e-fe37b03266ae | 2022-06-01 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
| RISPERIDONE | RISPERIDONE | Aphena Pharma Solutions - Tennessee, LLC | ac152803-d75f-4c3c-bc49-8663b21a3a82 | 2019-04-29 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 27241-001 | RISPERIDONE | RISPERIDONE | Ajanta Pharma Limited | ANDA | Current |
| 27241-001 | RISPERIDONE | RISPERIDONE | Ajanta Pharma Limited | ANDA | Current |
| 27241-001 | RISPERIDONE | RISPERIDONE | Ajanta Pharma Limited | ANDA | Current |
| 27241-001 | RISPERIDONE | RISPERIDONE | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-001 | RISPERIDONE | RISPERIDONE | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-002 | RISPERIDONE | RISPERIDONE | Ajanta Pharma Limited | ANDA | Current |
| 27241-002 | RISPERIDONE | RISPERIDONE | Ajanta Pharma Limited | ANDA | Current |
| 27241-002 | RISPERIDONE | RISPERIDONE | Ajanta Pharma Limited | ANDA | Current |
| 27241-002 | RISPERIDONE | RISPERIDONE | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-002 | RISPERIDONE | RISPERIDONE | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-003 | RISPERIDONE | RISPERIDONE | Ajanta Pharma Limited | ANDA | Current |
| 27241-003 | RISPERIDONE | RISPERIDONE | Ajanta Pharma Limited | ANDA | Current |
| 27241-003 | RISPERIDONE | RISPERIDONE | Ajanta Pharma Limited | ANDA | Current |
| 27241-003 | RISPERIDONE | RISPERIDONE | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-003 | RISPERIDONE | RISPERIDONE | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-004 | RISPERIDONE | RISPERIDONE | Ajanta Pharma Limited | ANDA | Current |
| 27241-004 | RISPERIDONE | RISPERIDONE | Ajanta Pharma Limited | ANDA | Current |
| 27241-004 | RISPERIDONE | RISPERIDONE | Ajanta Pharma Limited | ANDA | Current |
| 27241-004 | RISPERIDONE | RISPERIDONE | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-004 | RISPERIDONE | RISPERIDONE | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-005 | RISPERIDONE | RISPERIDONE | Ajanta Pharma Limited | ANDA | Current |
| 27241-005 | RISPERIDONE | RISPERIDONE | Ajanta Pharma Limited | ANDA | Current |
| 27241-005 | RISPERIDONE | RISPERIDONE | Ajanta Pharma Limited | ANDA | Current |
| 27241-005 | RISPERIDONE | RISPERIDONE | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-005 | RISPERIDONE | RISPERIDONE | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-006 | RISPERIDONE | RISPERIDONE | Ajanta Pharma Limited | ANDA | Current |
| 27241-006 | RISPERIDONE | RISPERIDONE | Ajanta Pharma Limited | ANDA | Current |
| 27241-006 | RISPERIDONE | RISPERIDONE | Ajanta Pharma Limited | ANDA | Current |
| 27241-006 | RISPERIDONE | RISPERIDONE | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-006 | RISPERIDONE | RISPERIDONE | Ajanta Pharma USA Inc. | ANDA | Current |
| 42495-004 | RISPERIDONE | RISPERIDONE | MSM Repackaging | ANDA | Current |
| 43063-908 | RISPERIDONE | RISPERIDONE | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-908 | RISPERIDONE | RISPERIDONE | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-908 | RISPERIDONE | RISPERIDONE | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-908 | RISPERIDONE | RISPERIDONE | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-908 | RISPERIDONE | RISPERIDONE | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-908 | RISPERIDONE | RISPERIDONE | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-908 | RISPERIDONE | RISPERIDONE | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-908 | RISPERIDONE | RISPERIDONE | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 50090-3340 | RISPERIDONE | RISPERIDONE | A-S Medication Solutions | ANDA | Current |
| 50090-3340 | RISPERIDONE | RISPERIDONE | A-S Medication Solutions | ANDA | Current |
| 50090-3341 | RISPERIDONE | RISPERIDONE | A-S Medication Solutions | ANDA | Current |
| 50090-3341 | RISPERIDONE | RISPERIDONE | A-S Medication Solutions | ANDA | Current |
| 50090-3341 | RISPERIDONE | RISPERIDONE | A-S Medication Solutions | ANDA | Current |
| 50090-3344 | RISPERIDONE | RISPERIDONE | A-S Medication Solutions | ANDA | Current |
| 50090-3344 | RISPERIDONE | RISPERIDONE | A-S Medication Solutions | ANDA | Current |
| 53808-1022 | RISPERIDONE | RISPERIDONE | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55700-392 | RISPERIDONE | RISPERIDONE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-897 | RISPERIDONE | RISPERIDONE | Quality Care Products, LLC | ANDA | Current |
| 55700-897 | RISPERIDONE | RISPERIDONE | Quality Care Products, LLC | ANDA | Current |
| 63187-264 | RISPERIDONE | RISPERIDONE | Proficient Rx LP | ANDA | Current |
| 63187-264 | RISPERIDONE | RISPERIDONE | Proficient Rx LP | ANDA | Current |
| 63187-264 | RISPERIDONE | RISPERIDONE | Proficient Rx LP | ANDA | Current |
| 63187-439 | RISPERIDONE | RISPERIDONE | Proficient Rx LP | ANDA | Current |
| 63187-439 | RISPERIDONE | RISPERIDONE | Proficient Rx LP | ANDA | Current |
| 63187-439 | RISPERIDONE | RISPERIDONE | Proficient Rx LP | ANDA | Current |
| 63187-642 | RISPERIDONE | RISPERIDONE | Proficient Rx LP | ANDA | Current |
| 63187-642 | RISPERIDONE | RISPERIDONE | Proficient Rx LP | ANDA | Current |
| 63187-642 | RISPERIDONE | RISPERIDONE | Proficient Rx LP | ANDA | Current |
| 63629-8121 | RISPERIDONE | RISPERIDONE | Bryant Ranch Prepack | ANDA | Current |
| 64725-0319 | RISPERIDONE | RISPERIDONE | TYA Pharmaceuticals | ANDA | Current |
| 64725-0321 | RISPERIDONE | RISPERIDONE | TYA Pharmaceuticals | ANDA | Current |
| 68071-2524 | RISPERIDONE | RISPERIDONE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2706 | RISPERIDONE | RISPERIDONE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3356 | RISPERIDONE | RISPERIDONE | Nucare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4618 | RISPERIDONE | RISPERIDONE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4618 | RISPERIDONE | RISPERIDONE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7211 | RISPERIDONE | RISPERIDONE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7211 | RISPERIDONE | RISPERIDONE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7211 | RISPERIDONE | RISPERIDONE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-0364 | RISPERIDONE | RISPERIDONE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0364 | RISPERIDONE | RISPERIDONE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0364 | RISPERIDONE | RISPERIDONE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0364 | RISPERIDONE | RISPERIDONE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0364 | RISPERIDONE | RISPERIDONE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0364 | RISPERIDONE | RISPERIDONE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0364 | RISPERIDONE | RISPERIDONE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0364 | RISPERIDONE | RISPERIDONE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0364 | RISPERIDONE | RISPERIDONE | REMEDYREPACK INC. | ANDA | Current |
| 70518-1502 | RISPERIDONE | RISPERIDONE | REMEDYREPACK INC. | ANDA | Current |