Application 206240
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ARIPIPRAZOLE | ARIPIPRAZOLE | TABLET;ORAL | 2MG | No | No |
| 002 | ARIPIPRAZOLE | ARIPIPRAZOLE | TABLET;ORAL | 5MG | No | No |
| 003 | ARIPIPRAZOLE | ARIPIPRAZOLE | TABLET;ORAL | 10MG | No | No |
| 004 | ARIPIPRAZOLE | ARIPIPRAZOLE | TABLET;ORAL | 15MG | No | No |
| 005 | ARIPIPRAZOLE | ARIPIPRAZOLE | TABLET;ORAL | 20MG | No | No |
| 006 | ARIPIPRAZOLE | ARIPIPRAZOLE | TABLET;ORAL | 30MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A206240-001 | ARIPIPRAZOLE | ARIPIPRAZOLE | 2MG | TABLET / ORAL | 2018-09-19 | ||
| A206240-002 | ARIPIPRAZOLE | ARIPIPRAZOLE | 5MG | TABLET / ORAL | 2018-09-19 | ||
| A206240-003 | ARIPIPRAZOLE | ARIPIPRAZOLE | 10MG | TABLET / ORAL | 2018-09-19 | ||
| A206240-004 | ARIPIPRAZOLE | ARIPIPRAZOLE | 15MG | TABLET / ORAL | 2018-09-19 | ||
| A206240-005 | ARIPIPRAZOLE | ARIPIPRAZOLE | 20MG | TABLET / ORAL | 2018-09-19 | ||
| A206240-006 | ARIPIPRAZOLE | ARIPIPRAZOLE | 30MG | TABLET / ORAL | 2018-09-19 |
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 | A206240-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | 2018-09-19 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A206240-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | 2018-09-19 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A206240-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | 2018-09-19 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A206240-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | 2018-09-19 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A206240-005 | ARIPIPRAZOLE | 20MG | TABLET / ORAL | 2018-09-19 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A206240-006 | ARIPIPRAZOLE | 30MG | TABLET / ORAL | 2018-09-19 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A206240-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | 2018-09-19 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A206240-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | 2018-09-19 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A206240-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | 2018-09-19 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A206240-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | 2018-09-19 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A206240-005 | ARIPIPRAZOLE | 20MG | TABLET / ORAL | 2018-09-19 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A206240-006 | ARIPIPRAZOLE | 30MG | TABLET / ORAL | 2018-09-19 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A206240-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | 2018-09-19 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A206240-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | 2018-09-19 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A206240-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | 2018-09-19 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A206240-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | 2018-09-19 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A206240-005 | ARIPIPRAZOLE | 20MG | TABLET / ORAL | 2018-09-19 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A206240-006 | ARIPIPRAZOLE | 30MG | TABLET / ORAL | 2018-09-19 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206240-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | 2018-09-19 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206240-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | 2018-09-19 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206240-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | 2018-09-19 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206240-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | 2018-09-19 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206240-005 | ARIPIPRAZOLE | 20MG | TABLET / ORAL | 2018-09-19 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206240-006 | ARIPIPRAZOLE | 30MG | TABLET / ORAL | 2018-09-19 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206240-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | 2018-09-19 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206240-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | 2018-09-19 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206240-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | 2018-09-19 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206240-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | 2018-09-19 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206240-005 | ARIPIPRAZOLE | 20MG | TABLET / ORAL | 2018-09-19 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206240-006 | ARIPIPRAZOLE | 30MG | TABLET / ORAL | 2018-09-19 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206240-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | 2018-09-19 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206240-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | 2018-09-19 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206240-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | 2018-09-19 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206240-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | 2018-09-19 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206240-005 | ARIPIPRAZOLE | 20MG | TABLET / ORAL | 2018-09-19 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206240-006 | ARIPIPRAZOLE | 30MG | TABLET / ORAL | 2018-09-19 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206240-001 | ARIPIPRAZOLE | 2MG | TABLET / ORAL | 2018-09-19 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206240-002 | ARIPIPRAZOLE | 5MG | TABLET / ORAL | 2018-09-19 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206240-003 | ARIPIPRAZOLE | 10MG | TABLET / ORAL | 2018-09-19 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206240-004 | ARIPIPRAZOLE | 15MG | TABLET / ORAL | 2018-09-19 | b8a1b40f171c… |
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 |
|---|---|---|---|---|---|---|
| ARIPIPRAZOLE | ARIPIPRAZOLE | Camber Pharmaceuticals, Inc. | 3718e585-06b9-40fd-a3eb-18b6497a4235 | 2017-08-08 | Boxed warning, Warnings, Adverse reactions | ARIPIPRAZOLE ARIPIPRAZOLE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.