Application 207098
- Type
- ANDA
- Sponsor
- TARO PHARM INDS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ILOPERIDONE | ILOPERIDONE | TABLET;ORAL | 1MG | No | No |
| 002 | ILOPERIDONE | ILOPERIDONE | TABLET;ORAL | 2MG | No | No |
| 003 | ILOPERIDONE | ILOPERIDONE | TABLET;ORAL | 4MG | No | No |
| 004 | ILOPERIDONE | ILOPERIDONE | TABLET;ORAL | 6MG | No | No |
| 005 | ILOPERIDONE | ILOPERIDONE | TABLET;ORAL | 8MG | No | No |
| 006 | ILOPERIDONE | ILOPERIDONE | TABLET;ORAL | 10MG | No | No |
| 007 | ILOPERIDONE | ILOPERIDONE | TABLET;ORAL | 12MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207098-001 | ILOPERIDONE | ILOPERIDONE | 1MG | TABLET / ORAL | 2019-07-22 | ||
| A207098-002 | ILOPERIDONE | ILOPERIDONE | 2MG | TABLET / ORAL | 2019-07-22 | ||
| A207098-003 | ILOPERIDONE | ILOPERIDONE | 4MG | TABLET / ORAL | 2019-07-22 | ||
| A207098-004 | ILOPERIDONE | ILOPERIDONE | 6MG | TABLET / ORAL | 2019-07-22 | ||
| A207098-005 | ILOPERIDONE | ILOPERIDONE | 8MG | TABLET / ORAL | 2019-07-22 | ||
| A207098-006 | ILOPERIDONE | ILOPERIDONE | 10MG | TABLET / ORAL | 2019-07-22 | ||
| A207098-007 | ILOPERIDONE | ILOPERIDONE | 12MG | TABLET / ORAL | 2019-07-22 |
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 | A207098-001 | ILOPERIDONE | 1MG | TABLET / ORAL | 2019-07-22 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A207098-002 | ILOPERIDONE | 2MG | TABLET / ORAL | 2019-07-22 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A207098-003 | ILOPERIDONE | 4MG | TABLET / ORAL | 2019-07-22 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A207098-004 | ILOPERIDONE | 6MG | TABLET / ORAL | 2019-07-22 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A207098-005 | ILOPERIDONE | 8MG | TABLET / ORAL | 2019-07-22 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A207098-006 | ILOPERIDONE | 10MG | TABLET / ORAL | 2019-07-22 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A207098-007 | ILOPERIDONE | 12MG | TABLET / ORAL | 2019-07-22 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A207098-001 | ILOPERIDONE | 1MG | TABLET / ORAL | 2019-07-22 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A207098-002 | ILOPERIDONE | 2MG | TABLET / ORAL | 2019-07-22 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A207098-003 | ILOPERIDONE | 4MG | TABLET / ORAL | 2019-07-22 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A207098-004 | ILOPERIDONE | 6MG | TABLET / ORAL | 2019-07-22 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A207098-005 | ILOPERIDONE | 8MG | TABLET / ORAL | 2019-07-22 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A207098-006 | ILOPERIDONE | 10MG | TABLET / ORAL | 2019-07-22 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A207098-007 | ILOPERIDONE | 12MG | TABLET / ORAL | 2019-07-22 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207098-001 | ILOPERIDONE | 1MG | TABLET / ORAL | 2019-07-22 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207098-002 | ILOPERIDONE | 2MG | TABLET / ORAL | 2019-07-22 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207098-003 | ILOPERIDONE | 4MG | TABLET / ORAL | 2019-07-22 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207098-004 | ILOPERIDONE | 6MG | TABLET / ORAL | 2019-07-22 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207098-005 | ILOPERIDONE | 8MG | TABLET / ORAL | 2019-07-22 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207098-006 | ILOPERIDONE | 10MG | TABLET / ORAL | 2019-07-22 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207098-007 | ILOPERIDONE | 12MG | TABLET / ORAL | 2019-07-22 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207098-001 | ILOPERIDONE | 1MG | TABLET / ORAL | 2019-07-22 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207098-002 | ILOPERIDONE | 2MG | TABLET / ORAL | 2019-07-22 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207098-003 | ILOPERIDONE | 4MG | TABLET / ORAL | 2019-07-22 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207098-004 | ILOPERIDONE | 6MG | TABLET / ORAL | 2019-07-22 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207098-005 | ILOPERIDONE | 8MG | TABLET / ORAL | 2019-07-22 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207098-006 | ILOPERIDONE | 10MG | TABLET / ORAL | 2019-07-22 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207098-007 | ILOPERIDONE | 12MG | TABLET / ORAL | 2019-07-22 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207098-001 | ILOPERIDONE | 1MG | TABLET / ORAL | 2019-07-22 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207098-002 | ILOPERIDONE | 2MG | TABLET / ORAL | 2019-07-22 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207098-003 | ILOPERIDONE | 4MG | TABLET / ORAL | 2019-07-22 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207098-004 | ILOPERIDONE | 6MG | TABLET / ORAL | 2019-07-22 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207098-005 | ILOPERIDONE | 8MG | TABLET / ORAL | 2019-07-22 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207098-006 | ILOPERIDONE | 10MG | TABLET / ORAL | 2019-07-22 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207098-007 | ILOPERIDONE | 12MG | TABLET / ORAL | 2019-07-22 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207098-001 | ILOPERIDONE | 1MG | TABLET / ORAL | 2019-07-22 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207098-002 | ILOPERIDONE | 2MG | TABLET / ORAL | 2019-07-22 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207098-003 | ILOPERIDONE | 4MG | TABLET / ORAL | 2019-07-22 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207098-004 | ILOPERIDONE | 6MG | TABLET / ORAL | 2019-07-22 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207098-005 | ILOPERIDONE | 8MG | TABLET / ORAL | 2019-07-22 | fd3edfee7708… |
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 |
|---|---|---|---|---|---|---|
| FANAPT | ILOPERIDONE | Vanda Pharmaceuticals Inc. | 33f60b40-3fca-11de-8f56-0002a5d5c51b | 2026-05-06 | Boxed warning, Warnings, Adverse reactions | ILOPERIDONE |
| ILOPERIDONE | ILOPERIDONE | Mylan Pharmaceuticals Inc. | eeb0fcfd-e4e8-4fb1-9635-901dc9446235 | 2025-03-13 | Boxed warning, Warnings, Adverse reactions | ILOPERIDONE ILOPERIDONE |
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 |
|---|---|---|---|---|---|
| 51672-4178 | Iloperidone | Iloperidone | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-4179 | Iloperidone | Iloperidone | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-4180 | Iloperidone | Iloperidone | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-4181 | Iloperidone | Iloperidone | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-4182 | Iloperidone | Iloperidone | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-4183 | Iloperidone | Iloperidone | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-4184 | Iloperidone | Iloperidone | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-4213 | Iloperidone | Iloperidone | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 74207 | ORIG | 2023-05-10 |