Application 078516
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RISPERIDONE | RISPERIDONE | TABLET, ORALLY DISINTEGRATING;ORAL | 0.5MG | No | No |
| 003 | RISPERIDONE | RISPERIDONE | TABLET, ORALLY DISINTEGRATING;ORAL | 2MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078516-001 | RISPERIDONE | RISPERIDONE | 0.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | |
| A078516-003 | RISPERIDONE | RISPERIDONE | 2MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078516-001 | AB |
| A078516-003 | 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 | A078516-001 | RISPERIDONE | 0.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078516-003 | RISPERIDONE | 2MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A078516-001 | RISPERIDONE | 0.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078516-003 | RISPERIDONE | 2MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078516-001 | RISPERIDONE | 0.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078516-003 | RISPERIDONE | 2MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078516-001 | RISPERIDONE | 0.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078516-003 | RISPERIDONE | 2MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078516-001 | RISPERIDONE | 0.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078516-003 | RISPERIDONE | 2MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078516-001 | RISPERIDONE | 0.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078516-003 | RISPERIDONE | 2MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078516-001 | RISPERIDONE | 0.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078516-003 | RISPERIDONE | 2MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078516-001 | RISPERIDONE | 0.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078516-003 | RISPERIDONE | 2MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078516-001 | RISPERIDONE | 0.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078516-003 | RISPERIDONE | 2MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078516-001 | RISPERIDONE | 0.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078516-003 | RISPERIDONE | 2MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078516-001 | RISPERIDONE | 0.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078516-003 | RISPERIDONE | 2MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078516-001 | RISPERIDONE | 0.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078516-003 | RISPERIDONE | 2MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078516-001 | RISPERIDONE | 0.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078516-003 | RISPERIDONE | 2MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078516-001 | RISPERIDONE | 0.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078516-003 | RISPERIDONE | 2MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078516-001 | RISPERIDONE | 0.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078516-003 | RISPERIDONE | 2MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078516-001 | RISPERIDONE | 0.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078516-003 | RISPERIDONE | 2MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078516-001 | RISPERIDONE | 0.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078516-003 | RISPERIDONE | 2MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078516-001 | RISPERIDONE | 0.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078516-003 | RISPERIDONE | 2MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078516-001 | RISPERIDONE | 0.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078516-003 | RISPERIDONE | 2MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A078516-001 | RISPERIDONE | 0.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A078516-003 | RISPERIDONE | 2MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2009-05-01 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-03-09 01:35 UTC | 2022-03 | A078516-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A078516-003 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A078516-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A078516-003 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A078516-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A078516-003 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A078516-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A078516-003 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A078516-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A078516-003 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A078516-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A078516-003 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A078516-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A078516-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A078516-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A078516-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A078516-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A078516-003 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A078516-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A078516-003 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A078516-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A078516-003 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A078516-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A078516-003 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A078516-001 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A078516-003 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A078516-001 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A078516-003 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A078516-001 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A078516-003 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A078516-001 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A078516-003 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A078516-001 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A078516-003 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A078516-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A078516-003 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A078516-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A078516-003 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A078516-001 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A078516-003 | AB | 1 | f41ea6bd6efb… |
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 | APOZEAL PHARMACEUTICALS INC | 4ab6d256-6590-45be-a5df-f505987f96c3 | 2026-08-30 | Boxed warning, Warnings, Adverse reactions | Risperidone RISPERIDONE |
| Risperidone | RISPERIDONE | Janssen Pharmaceuticals, Inc. | 701e1cd8-2868-4d29-85a9-a2212c88165f | 2026-08-20 | Boxed warning, Warnings, Adverse reactions | Risperidone RISPERIDONE |
| RISPERIDONE | RISPERIDONE | Amerisyn LLC | 58b7504f-c4a3-ef1b-e063-6394a90ac0f3 | 2026-08-10 | Boxed warning, Warnings, Adverse reactions | RISPERIDONE RISPERIDONE |
| 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 | 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 | Coupler LLC | 50216d94-7667-bd6a-e063-6394a90a8155 | 2026-04-23 | 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 | Solco Healthcare US, LLC | 43aa2a4f-1123-4f86-800b-9218882f7bcd | 2026-03-31 | Boxed warning, Warnings, Adverse reactions | Risperidone RISPERIDONE |
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 |
|---|---|---|---|---|---|
| 65841-640 | risperidone | risperidone | Zydus Lifesciences Limited | ANDA | Current |
| 65841-640 | risperidone | risperidone | Cadila Healthcare Limited | ANDA | Current |
| 65841-640 | risperidone | risperidone | Cadila Healthcare Limited | ANDA | Current |
| 65841-641 | risperidone | risperidone | Zydus Lifesciences Limited | ANDA | Current |
| 65841-641 | risperidone | risperidone | Cadila Healthcare Limited | ANDA | Current |
| 65841-641 | risperidone | risperidone | Cadila Healthcare Limited | ANDA | Current |
| 65841-642 | risperidone | risperidone | Zydus Lifesciences Limited | ANDA | Current |
| 65841-642 | risperidone | risperidone | Cadila Healthcare Limited | ANDA | Current |
| 65841-642 | risperidone | risperidone | Cadila Healthcare Limited | ANDA | Current |
| 68382-154 | risperidone | risperidone | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-154 | risperidone | risperidone | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-154 | risperidone | risperidone | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-155 | risperidone | risperidone | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-155 | risperidone | risperidone | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-155 | risperidone | risperidone | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-156 | risperidone | risperidone | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-156 | risperidone | risperidone | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-156 | risperidone | risperidone | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |