Application 207231
- Type
- ANDA
- Sponsor
- INVENTIA
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 |
|---|---|---|---|---|---|---|---|
| A207231-001 | ILOPERIDONE | ILOPERIDONE | 1MG | TABLET / ORAL | 2016-11-28 | ||
| A207231-002 | ILOPERIDONE | ILOPERIDONE | 2MG | TABLET / ORAL | 2016-11-28 | ||
| A207231-003 | ILOPERIDONE | ILOPERIDONE | 4MG | TABLET / ORAL | 2016-11-28 | ||
| A207231-004 | ILOPERIDONE | ILOPERIDONE | 6MG | TABLET / ORAL | 2016-11-28 | ||
| A207231-005 | ILOPERIDONE | ILOPERIDONE | 8MG | TABLET / ORAL | 2016-11-28 | ||
| A207231-006 | ILOPERIDONE | ILOPERIDONE | 10MG | TABLET / ORAL | 2016-11-28 | ||
| A207231-007 | ILOPERIDONE | ILOPERIDONE | 12MG | TABLET / ORAL | 2016-11-28 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A207231-001 | ILOPERIDONE | 1MG | TABLET / ORAL | 2016-11-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A207231-002 | ILOPERIDONE | 2MG | TABLET / ORAL | 2016-11-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A207231-003 | ILOPERIDONE | 4MG | TABLET / ORAL | 2016-11-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A207231-004 | ILOPERIDONE | 6MG | TABLET / ORAL | 2016-11-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A207231-005 | ILOPERIDONE | 8MG | TABLET / ORAL | 2016-11-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A207231-006 | ILOPERIDONE | 10MG | TABLET / ORAL | 2016-11-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A207231-007 | ILOPERIDONE | 12MG | TABLET / ORAL | 2016-11-28 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207231-001 | ILOPERIDONE | 1MG | TABLET / ORAL | 2016-11-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207231-002 | ILOPERIDONE | 2MG | TABLET / ORAL | 2016-11-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207231-003 | ILOPERIDONE | 4MG | TABLET / ORAL | 2016-11-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207231-004 | ILOPERIDONE | 6MG | TABLET / ORAL | 2016-11-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207231-005 | ILOPERIDONE | 8MG | TABLET / ORAL | 2016-11-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207231-006 | ILOPERIDONE | 10MG | TABLET / ORAL | 2016-11-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207231-007 | ILOPERIDONE | 12MG | TABLET / ORAL | 2016-11-28 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207231-001 | ILOPERIDONE | 1MG | TABLET / ORAL | 2016-11-28 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207231-002 | ILOPERIDONE | 2MG | TABLET / ORAL | 2016-11-28 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207231-003 | ILOPERIDONE | 4MG | TABLET / ORAL | 2016-11-28 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207231-004 | ILOPERIDONE | 6MG | TABLET / ORAL | 2016-11-28 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207231-005 | ILOPERIDONE | 8MG | TABLET / ORAL | 2016-11-28 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207231-006 | ILOPERIDONE | 10MG | TABLET / ORAL | 2016-11-28 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207231-007 | ILOPERIDONE | 12MG | TABLET / ORAL | 2016-11-28 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207231-001 | ILOPERIDONE | 1MG | TABLET / ORAL | 2016-11-28 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207231-002 | ILOPERIDONE | 2MG | TABLET / ORAL | 2016-11-28 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207231-003 | ILOPERIDONE | 4MG | TABLET / ORAL | 2016-11-28 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207231-004 | ILOPERIDONE | 6MG | TABLET / ORAL | 2016-11-28 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207231-005 | ILOPERIDONE | 8MG | TABLET / ORAL | 2016-11-28 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207231-006 | ILOPERIDONE | 10MG | TABLET / ORAL | 2016-11-28 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207231-007 | ILOPERIDONE | 12MG | TABLET / ORAL | 2016-11-28 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207231-001 | ILOPERIDONE | 1MG | TABLET / ORAL | 2016-11-28 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207231-002 | ILOPERIDONE | 2MG | TABLET / ORAL | 2016-11-28 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207231-003 | ILOPERIDONE | 4MG | TABLET / ORAL | 2016-11-28 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207231-004 | ILOPERIDONE | 6MG | TABLET / ORAL | 2016-11-28 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207231-005 | ILOPERIDONE | 8MG | TABLET / ORAL | 2016-11-28 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207231-006 | ILOPERIDONE | 10MG | TABLET / ORAL | 2016-11-28 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207231-007 | ILOPERIDONE | 12MG | TABLET / ORAL | 2016-11-28 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207231-001 | ILOPERIDONE | 1MG | TABLET / ORAL | 2016-11-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207231-002 | ILOPERIDONE | 2MG | TABLET / ORAL | 2016-11-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207231-003 | ILOPERIDONE | 4MG | TABLET / ORAL | 2016-11-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207231-004 | ILOPERIDONE | 6MG | TABLET / ORAL | 2016-11-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207231-005 | ILOPERIDONE | 8MG | TABLET / ORAL | 2016-11-28 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-07-19 19:46 UTC | 2019-07 | A207231-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A207231-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A207231-003 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A207231-004 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A207231-005 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A207231-006 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A207231-007 | 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 |
|---|---|---|---|---|---|---|
| ILOPERIDONE | ILOPERIDONE | Mylan Pharmaceuticals Inc. | eeb0fcfd-e4e8-4fb1-9635-901dc9446235 | 2025-03-13 | Boxed warning, Warnings, Adverse reactions | 207231 ANDA207231 0378-0634 0378-0632 0378-0631 0378-0630 0378-0635 0378-0636 0378-0633 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-0630 | Iloperidone | Iloperidone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0630 | Iloperidone | Iloperidone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0631 | Iloperidone | Iloperidone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0631 | Iloperidone | Iloperidone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0632 | Iloperidone | Iloperidone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0632 | Iloperidone | Iloperidone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0633 | Iloperidone | Iloperidone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0633 | Iloperidone | Iloperidone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0634 | Iloperidone | Iloperidone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0634 | Iloperidone | Iloperidone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0635 | Iloperidone | Iloperidone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0635 | Iloperidone | Iloperidone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0636 | Iloperidone | Iloperidone | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0636 | Iloperidone | Iloperidone | Mylan Pharmaceuticals Inc. | ANDA | Current |