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 | Torrent Pharmaceuticals Limited | a6347895-5f16-43b4-92a0-b9904ac81937 | 2026-03-03 | Boxed warning, Warnings, Adverse reactions | Risperidone RISPERIDONE |
| risperidone | RISPERIDONE | Lupin Pharmaceuticals, Inc. | b462e48c-ef1d-4591-8fca-6b5829d8ed90 | 2026-02-24 | Boxed warning, Warnings, Adverse reactions | risperidone RISPERIDONE |
| RISPERIDONE | RISPERIDONE | REMEDYREPACK INC. | 2776a647-678d-465c-9db3-4a9459ce779e | 2026-01-28 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE RISPERIDONE |
| RISPERIDONE | RISPERIDONE | REMEDYREPACK INC. | 5d9519af-5a5e-47ce-8a0f-9b9cfac00e19 | 2026-01-26 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE RISPERIDONE |
| RISPERIDONE | RISPERIDONE | REMEDYREPACK INC. | ee7d6779-7421-4761-99d2-ccbfde9385a8 | 2026-01-26 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE RISPERIDONE |
| RISPERIDONE | RISPERIDONE | REMEDYREPACK INC. | 101b2d4d-4740-4225-94bc-aecc05d82c6b | 2026-01-26 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE RISPERIDONE |
| risperidone | RISPERIDONE | Major Pharmaceuticals | d5abd75f-7f4a-4a7d-b849-82fce88f5ff7 | 2026-01-02 | Boxed warning, Warnings, Adverse reactions | risperidone RISPERIDONE |
| Risperidone | RISPERIDONE | Westminster Pharmaceuticals, LLC | 07d43bf6-a695-453a-a5c7-9581effe585c | 2025-12-07 | Boxed warning, Warnings, Adverse reactions | Risperidone RISPERIDONE |
| Risperidone | RISPERIDONE | Golden State Medical Supply, Inc. | 448467a3-44ef-c87b-e063-6294a90a5ec9 | 2025-11-26 | Boxed warning, Warnings, Adverse reactions | Risperidone RISPERIDONE |
| Risperidone | RISPERIDONE | American Health Packaging | f11dae15-b057-4258-9229-3819d0c980fe | 2025-11-18 | Boxed warning, Warnings, Adverse reactions | Risperidone RISPERIDONE |
| RISPERDAL CONSTA | RISPERIDONE | Janssen Pharmaceuticals, Inc. | bb34ee82-d2c2-43b8-ba21-2825c0954691 | 2025-11-05 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| UZEDY | RISPERIDONE | Teva Pharmaceuticals USA, Inc. | 734eb776-4be0-4808-834b-0d8b0f9e021e | 2025-10-09 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE |
| Risperidone | RISPERIDONE | Jubilant Cadista Pharmacuticals Inc. | 739dcf8a-ed73-5eb0-899b-7e51cb73c335 | 2025-10-08 | Boxed warning, Warnings, Adverse reactions | Risperidone RISPERIDONE |
| RISPERIDONE | RISPERIDONE | Ajanta Pharma USA Inc. | 095630bd-a77e-434e-94ee-f13da445d8f2 | 2025-09-16 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE RISPERIDONE |
| Risperidone | RISPERIDONE | AvKARE | 3d4c51e2-b09b-9fd0-e063-6294a90ae699 | 2025-08-26 | Boxed warning, Warnings, Adverse reactions | Risperidone RISPERIDONE |
| Risperidone | RISPERIDONE | REMEDYREPACK INC. | 3261e8cf-cc6e-4011-9246-aee623ad8971 | 2025-08-12 | Boxed warning, Warnings, Adverse reactions | Risperidone RISPERIDONE |
| Risperidone | RISPERIDONE | REMEDYREPACK INC. | 339ec0af-c0f0-4115-8cdb-8f052e633f47 | 2025-08-06 | Boxed warning, Warnings, Adverse reactions | Risperidone RISPERIDONE |
| Risperidone | RISPERIDONE | Bryant Ranch Prepack | 4604052d-dbda-4535-b7b8-1bd72a129aca | 2025-07-29 | Boxed warning, Warnings, Adverse reactions | Risperidone RISPERIDONE |
| Risperidone | RISPERIDONE | NuCare Pharmaceuticals, Inc. | 390904c2-fcfa-466e-e063-6394a90a03af | 2025-07-03 | Boxed warning, Warnings, Adverse reactions | Risperidone RISPERIDONE |
| Risperidone | RISPERIDONE | Jubilant Cadista Pharmacuticals Inc. | 39d41b28-93eb-446b-9652-7432858ccbab | 2025-07-02 | 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 |