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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201003-005 | RISPERIDONE | 3MG | TABLET / ORAL | AB | 2011-08-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201003-006 | RISPERIDONE | 4MG | TABLET / ORAL | AB | 2011-08-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201003-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | AB | 2011-08-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201003-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | AB | 2011-08-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201003-003 | RISPERIDONE | 1MG | TABLET / ORAL | AB | 2011-08-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201003-004 | RISPERIDONE | 2MG | TABLET / ORAL | AB | 2011-08-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201003-005 | RISPERIDONE | 3MG | TABLET / ORAL | AB | 2011-08-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201003-006 | RISPERIDONE | 4MG | TABLET / ORAL | AB | 2011-08-24 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201003-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | AB | 2011-08-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201003-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | AB | 2011-08-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201003-003 | RISPERIDONE | 1MG | TABLET / ORAL | AB | 2011-08-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201003-004 | RISPERIDONE | 2MG | TABLET / ORAL | AB | 2011-08-24 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 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… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201003-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201003-006 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201003-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201003-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201003-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201003-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201003-005 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201003-006 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201003-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201003-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201003-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201003-004 | 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 | Coupler LLC | 5643c32b-310e-4888-e063-6394a90ab62f | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
| RISPERIDONE | RISPERIDONE | REMEDYREPACK INC. | ee495f20-c668-4d8f-9684-1029a4f232db | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 70518-1502 |
| RISPERIDONE | RISPERIDONE | REMEDYREPACK INC. | 03d3b52d-3a7d-4595-84c9-332da6ca9171 | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 70518-0364 |
| RISPERIDONE | RISPERIDONE | Coupler LLC | 52bb35ac-1f7d-bfbe-e063-6294a90aa2b9 | 2026-06-09 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
| RISPERIDONE | RISPERIDONE | A-S Medication Solutions | a6767972-2d3f-482b-80bd-ac93e28fdd05 | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 50090-3344 50090-3340 |
| RISPERIDONE | RISPERIDONE | PD-Rx Pharmaceuticals, Inc. | bdb08381-dbfc-442e-8d3c-22d3a0f2f6c5 | 2026-03-23 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
| RISPERIDONE | RISPERIDONE | REMEDYREPACK INC. | 2776a647-678d-465c-9db3-4a9459ce779e | 2026-01-28 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
| RISPERIDONE | RISPERIDONE | REMEDYREPACK INC. | 5d9519af-5a5e-47ce-8a0f-9b9cfac00e19 | 2026-01-26 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
| RISPERIDONE | RISPERIDONE | REMEDYREPACK INC. | ee7d6779-7421-4761-99d2-ccbfde9385a8 | 2026-01-26 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
| RISPERIDONE | RISPERIDONE | REMEDYREPACK INC. | 101b2d4d-4740-4225-94bc-aecc05d82c6b | 2026-01-26 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
| RISPERIDONE | RISPERIDONE | Ajanta Pharma USA Inc. | 095630bd-a77e-434e-94ee-f13da445d8f2 | 2025-09-16 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 27241-002 27241-006 27241-001 27241-003 27241-005 27241-004 |
| RISPERIDONE | RISPERIDONE | PD-Rx Pharmaceuticals, Inc. | be388943-fe0c-4c82-ac8e-3df9f77b2891 | 2025-04-15 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 43063-908 |
| Risperidone | RISPERIDONE | Direct_Rx | 0b784f21-fc02-6542-e063-6294a90a285e | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
| RISPERIDONE | RISPERIDONE | NuCare Pharmaceuticals,Inc. | 79648a52-1364-c25b-e053-2a91aa0a8ea4 | 2024-06-12 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 68071-4618 |
| RISPERIDONE | RISPERIDONE | Bryant Ranch Prepack | 420cfeef-0061-43b9-9491-dbd6ad866e55 | 2024-05-29 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
| RISPERIDONE | RISPERIDONE | Bryant Ranch Prepack | aab773b2-a605-4cf8-a301-57e390fe67a6 | 2024-05-29 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
| RISPERIDONE | RISPERIDONE | Bryant Ranch Prepack | 2f83d3e9-04ab-4b24-ad1f-7ed2e784298a | 2024-05-29 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
| RISPERIDONE | RISPERIDONE | Bryant Ranch Prepack | e35be034-6275-41fb-bec4-9ae451458701 | 2024-04-11 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
| RISPERIDONE | RISPERIDONE | A-S Medication Solutions | 523d4f99-1d6f-413f-9d6e-2ca430aaac14 | 2024-01-04 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 50090-3341 |
| RISPERIDONE | RISPERIDONE | Aphena Pharma Solutions - Tennessee, LLC | bda104ac-1eea-4a1a-836a-24bcc034b90f | 2022-11-09 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
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 |