Application 076288
- Type
- ANDA
- Sponsor
- MYLAN
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 |
|---|---|---|---|---|---|---|---|
| A076288-001 | RISPERIDONE | RISPERIDONE | 0.25MG | TABLET / ORAL | 2008-09-15 | ||
| A076288-002 | RISPERIDONE | RISPERIDONE | 0.5MG | TABLET / ORAL | 2008-09-15 | ||
| A076288-003 | RISPERIDONE | RISPERIDONE | 1MG | TABLET / ORAL | 2008-09-15 | ||
| A076288-004 | RISPERIDONE | RISPERIDONE | 2MG | TABLET / ORAL | 2008-09-15 | ||
| A076288-005 | RISPERIDONE | RISPERIDONE | 3MG | TABLET / ORAL | 2008-09-15 | ||
| A076288-006 | RISPERIDONE | RISPERIDONE | 4MG | TABLET / ORAL | 2008-09-15 |
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 | A076288-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | 2008-09-15 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076288-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | 2008-09-15 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076288-003 | RISPERIDONE | 1MG | TABLET / ORAL | 2008-09-15 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076288-004 | RISPERIDONE | 2MG | TABLET / ORAL | 2008-09-15 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076288-005 | RISPERIDONE | 3MG | TABLET / ORAL | 2008-09-15 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076288-006 | RISPERIDONE | 4MG | TABLET / ORAL | 2008-09-15 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076288-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | 2008-09-15 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076288-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | 2008-09-15 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076288-003 | RISPERIDONE | 1MG | TABLET / ORAL | 2008-09-15 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076288-004 | RISPERIDONE | 2MG | TABLET / ORAL | 2008-09-15 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076288-005 | RISPERIDONE | 3MG | TABLET / ORAL | 2008-09-15 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076288-006 | RISPERIDONE | 4MG | TABLET / ORAL | 2008-09-15 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076288-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | 2008-09-15 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076288-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | 2008-09-15 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076288-003 | RISPERIDONE | 1MG | TABLET / ORAL | 2008-09-15 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076288-004 | RISPERIDONE | 2MG | TABLET / ORAL | 2008-09-15 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076288-005 | RISPERIDONE | 3MG | TABLET / ORAL | 2008-09-15 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076288-006 | RISPERIDONE | 4MG | TABLET / ORAL | 2008-09-15 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076288-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | 2008-09-15 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076288-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | 2008-09-15 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076288-003 | RISPERIDONE | 1MG | TABLET / ORAL | 2008-09-15 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076288-004 | RISPERIDONE | 2MG | TABLET / ORAL | 2008-09-15 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076288-005 | RISPERIDONE | 3MG | TABLET / ORAL | 2008-09-15 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076288-006 | RISPERIDONE | 4MG | TABLET / ORAL | 2008-09-15 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076288-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | 2008-09-15 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076288-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | 2008-09-15 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076288-003 | RISPERIDONE | 1MG | TABLET / ORAL | 2008-09-15 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076288-004 | RISPERIDONE | 2MG | TABLET / ORAL | 2008-09-15 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076288-005 | RISPERIDONE | 3MG | TABLET / ORAL | 2008-09-15 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076288-006 | RISPERIDONE | 4MG | TABLET / ORAL | 2008-09-15 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076288-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | 2008-09-15 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076288-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | 2008-09-15 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076288-003 | RISPERIDONE | 1MG | TABLET / ORAL | 2008-09-15 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076288-004 | RISPERIDONE | 2MG | TABLET / ORAL | 2008-09-15 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076288-005 | RISPERIDONE | 3MG | TABLET / ORAL | 2008-09-15 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076288-006 | RISPERIDONE | 4MG | TABLET / ORAL | 2008-09-15 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076288-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | 2008-09-15 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076288-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | 2008-09-15 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076288-003 | RISPERIDONE | 1MG | TABLET / ORAL | 2008-09-15 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076288-004 | RISPERIDONE | 2MG | TABLET / ORAL | 2008-09-15 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A076288-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076288-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076288-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076288-004 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076288-005 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076288-006 | AB | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A076288-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A076288-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A076288-003 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A076288-004 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A076288-005 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A076288-006 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A076288-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A076288-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A076288-003 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A076288-004 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A076288-005 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A076288-006 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A076288-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A076288-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A076288-003 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A076288-004 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A076288-005 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A076288-006 | AB | 1 | ea99ee380514… |
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 | Amneal Pharmaceuticals LLC | d526af85-ee70-4657-a27e-d451027ffd9e | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | Risperidone RISPERIDONE |
| RISPERIDONE | RISPERIDONE | Coupler LLC | 5643c32b-310e-4888-e063-6394a90ab62f | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE RISPERIDONE |
| Risperidone | RISPERIDONE | ATLANTIC BIOLOGICALS CORP. | dc8c6638-f487-49df-a265-78caa93e43d8 | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | Risperidone RISPERIDONE |
| RISPERIDONE | RISPERIDONE | REMEDYREPACK INC. | ee495f20-c668-4d8f-9684-1029a4f232db | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE RISPERIDONE |
| Risperidone | RISPERIDONE | Coupler LLC | 55f3ebec-a742-48fc-e063-6394a90a1452 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | Risperidone RISPERIDONE |
| Risperidone | RISPERIDONE | ANI Pharmaceuticals, Inc. | 1f47ec91-602f-4fba-8f7e-a5698760b655 | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | Risperidone RISPERIDONE |
| RISPERIDONE | RISPERIDONE | REMEDYREPACK INC. | 03d3b52d-3a7d-4595-84c9-332da6ca9171 | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE RISPERIDONE |
| Risperidone | RISPERIDONE | Janssen Pharmaceutical, Inc. | 701e1cd8-2868-4d29-85a9-a2212c88165f | 2026-06-12 | Boxed warning, Warnings, Adverse reactions | Risperidone RISPERIDONE |
| Risperidone | RISPERIDONE | REMEDYREPACK INC. | c84807bd-35d7-4138-8989-42617d69293a | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | Risperidone RISPERIDONE |
| RISPERIDONE | RISPERIDONE | Coupler LLC | 52bb35ac-1f7d-bfbe-e063-6294a90aa2b9 | 2026-06-09 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE RISPERIDONE |
| RISPERDAL | RISPERIDONE | Janssen Pharmaceuticals, Inc. | 7e117c7e-02fc-4343-92a1-230061dfc5e0 | 2026-05-28 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| Rykindo extended-release microspheres | RISPERIDONE | Shandong Luye Pharmaceutical Co., Ltd. | 58534c96-96f5-4c2e-a061-92d4506aee91 | 2026-05-26 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| Risperidone | RISPERIDONE | PD-Rx Pharmaceuticals, Inc. | e72a2768-815f-47bf-b2f9-16a93dd10684 | 2026-04-28 | Boxed warning, Warnings, Adverse reactions | Risperidone RISPERIDONE |
| Risperidone | RISPERIDONE | REMEDYREPACK INC. | 8a4158fe-37d4-4c97-9c44-1c3489fe2a9f | 2026-04-15 | Boxed warning, Warnings, Adverse reactions | Risperidone RISPERIDONE |
| Risperidone | RISPERIDONE | REMEDYREPACK INC. | ab1cf6fd-9932-47fc-8736-476cc53a13fa | 2026-04-15 | Boxed warning, Warnings, Adverse reactions | Risperidone RISPERIDONE |
| risperidone | RISPERIDONE | Cardinal Health 107, LLC | 3ce21196-4aa0-469b-8f04-6650b2c48cb5 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | risperidone RISPERIDONE |
| RISPERIDONE | RISPERIDONE | A-S Medication Solutions | a6767972-2d3f-482b-80bd-ac93e28fdd05 | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE RISPERIDONE |
| Risperidone | RISPERIDONE | Solco Healthcare US, LLC | 43aa2a4f-1123-4f86-800b-9218882f7bcd | 2026-03-31 | Boxed warning, Warnings, Adverse reactions | Risperidone RISPERIDONE |
| Risperidone | RISPERIDONE | Amici Pharma, Inc. | ca41c144-224a-4d57-88d7-8778e6c69ed2 | 2026-03-26 | Boxed warning, Warnings, Adverse reactions | Risperidone RISPERIDONE |
| RISPERIDONE | RISPERIDONE | PD-Rx Pharmaceuticals, Inc. | bdb08381-dbfc-442e-8d3c-22d3a0f2f6c5 | 2026-03-23 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE RISPERIDONE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-3502 | Risperidone | risperidone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3502 | Risperidone | risperidone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3502 | Risperidone | risperidone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3505 | Risperidone | risperidone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3505 | Risperidone | risperidone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3505 | Risperidone | risperidone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3511 | Risperidone | risperidone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3511 | Risperidone | risperidone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3511 | Risperidone | risperidone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3512 | Risperidone | risperidone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3512 | Risperidone | risperidone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3512 | Risperidone | risperidone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3513 | Risperidone | risperidone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3513 | Risperidone | risperidone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3513 | Risperidone | risperidone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3514 | Risperidone | risperidone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3514 | Risperidone | risperidone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3514 | Risperidone | risperidone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0615-7505 | Risperidone | risperidone | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7506 | Risperidone | risperidone | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7506 | Risperidone | risperidone | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7507 | Risperidone | risperidone | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7507 | Risperidone | risperidone | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 43353-754 | Risperidone | risperidone | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-755 | Risperidone | risperidone | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-757 | Risperidone | risperidone | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-766 | Risperidone | risperidone | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 51079-460 | Risperidone | risperidone | Mylan Institutional Inc. | ANDA | Current |
| 51079-461 | Risperidone | risperidone | Mylan Institutional Inc. | ANDA | Current |
| 51079-462 | Risperidone | risperidone | Mylan Institutional Inc. | ANDA | Current |
| 51079-462 | Risperidone | risperidone | Mylan Institutional Inc. | ANDA | Current |
| 51079-463 | Risperidone | risperidone | Mylan Institutional Inc. | ANDA | Current |
| 51079-463 | Risperidone | risperidone | Mylan Institutional Inc. | ANDA | Current |
| 51079-463 | Risperidone | risperidone | Mylan Institutional Inc. | ANDA | Current |
| 51079-464 | Risperidone | risperidone | Mylan Institutional Inc. | ANDA | Current |
| 51079-464 | Risperidone | risperidone | Mylan Institutional Inc. | ANDA | Current |
| 51079-464 | Risperidone | risperidone | Mylan Institutional Inc. | ANDA | Current |
| 51079-465 | Risperidone | risperidone | Mylan Institutional Inc. | ANDA | Current |
| 51079-465 | Risperidone | risperidone | Mylan Institutional Inc. | ANDA | Current |
| 51079-465 | Risperidone | risperidone | Mylan Institutional Inc. | ANDA | Current |
| 53808-0624 | Risperidone | risperidone | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0876 | Risperidone | risperidone | State of Florida DOH Central Pharmacy | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 44300 | ORIG | 2008-09-19 |