Application 211149
- Type
- ANDA
- Sponsor
- TEVA PHARMS USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PALIPERIDONE PALMITATE | PALIPERIDONE PALMITATE | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 39MG/0.25ML (39MG/0.25ML) | No | No |
| 002 | PALIPERIDONE PALMITATE | PALIPERIDONE PALMITATE | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 78MG/0.5ML (78MG/0.5ML) | No | No |
| 003 | PALIPERIDONE PALMITATE | PALIPERIDONE PALMITATE | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 117MG/0.75ML (117MG/0.75ML) | No | No |
| 004 | PALIPERIDONE PALMITATE | PALIPERIDONE PALMITATE | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 156MG/ML (156MG/ML) | No | No |
| 005 | PALIPERIDONE PALMITATE | PALIPERIDONE PALMITATE | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 234MG/1.5ML (156MG/ML) | No | No |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211149-001 | PALIPERIDONE PALMITATE | 39MG/0.25ML (39MG/0.25ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | 2021-07-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211149-002 | PALIPERIDONE PALMITATE | 78MG/0.5ML (78MG/0.5ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | 2021-07-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211149-003 | PALIPERIDONE PALMITATE | 117MG/0.75ML (117MG/0.75ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | 2021-07-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211149-004 | PALIPERIDONE PALMITATE | 156MG/ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | 2021-07-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211149-005 | PALIPERIDONE PALMITATE | 234MG/1.5ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | 2021-07-06 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211149-001 | PALIPERIDONE PALMITATE | 39MG/0.25ML (39MG/0.25ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | 2021-07-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211149-002 | PALIPERIDONE PALMITATE | 78MG/0.5ML (78MG/0.5ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | 2021-07-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211149-003 | PALIPERIDONE PALMITATE | 117MG/0.75ML (117MG/0.75ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | 2021-07-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211149-004 | PALIPERIDONE PALMITATE | 156MG/ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | 2021-07-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211149-005 | PALIPERIDONE PALMITATE | 234MG/1.5ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | 2021-07-06 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211149-001 | PALIPERIDONE PALMITATE | 39MG/0.25ML (39MG/0.25ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | 2021-07-06 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211149-002 | PALIPERIDONE PALMITATE | 78MG/0.5ML (78MG/0.5ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | 2021-07-06 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211149-003 | PALIPERIDONE PALMITATE | 117MG/0.75ML (117MG/0.75ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | 2021-07-06 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211149-004 | PALIPERIDONE PALMITATE | 156MG/ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | 2021-07-06 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211149-005 | PALIPERIDONE PALMITATE | 234MG/1.5ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AB | 2021-07-06 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A211149-001 | PALIPERIDONE PALMITATE | 39MG/0.25ML (39MG/0.25ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 2021-07-06 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A211149-002 | PALIPERIDONE PALMITATE | 78MG/0.5ML (78MG/0.5ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 2021-07-06 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A211149-003 | PALIPERIDONE PALMITATE | 117MG/0.75ML (117MG/0.75ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 2021-07-06 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A211149-004 | PALIPERIDONE PALMITATE | 156MG/ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 2021-07-06 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A211149-005 | PALIPERIDONE PALMITATE | 234MG/1.5ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 2021-07-06 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A211149-001 | PALIPERIDONE PALMITATE | 39MG/0.25ML (39MG/0.25ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 2021-07-06 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A211149-002 | PALIPERIDONE PALMITATE | 78MG/0.5ML (78MG/0.5ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 2021-07-06 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A211149-003 | PALIPERIDONE PALMITATE | 117MG/0.75ML (117MG/0.75ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 2021-07-06 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A211149-004 | PALIPERIDONE PALMITATE | 156MG/ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 2021-07-06 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A211149-005 | PALIPERIDONE PALMITATE | 234MG/1.5ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 2021-07-06 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A211149-001 | PALIPERIDONE PALMITATE | 39MG/0.25ML (39MG/0.25ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 2021-07-06 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A211149-002 | PALIPERIDONE PALMITATE | 78MG/0.5ML (78MG/0.5ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 2021-07-06 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A211149-003 | PALIPERIDONE PALMITATE | 117MG/0.75ML (117MG/0.75ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 2021-07-06 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A211149-004 | PALIPERIDONE PALMITATE | 156MG/ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 2021-07-06 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A211149-005 | PALIPERIDONE PALMITATE | 234MG/1.5ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 2021-07-06 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A211149-001 | PALIPERIDONE PALMITATE | 39MG/0.25ML (39MG/0.25ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 2021-07-06 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A211149-002 | PALIPERIDONE PALMITATE | 78MG/0.5ML (78MG/0.5ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 2021-07-06 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A211149-003 | PALIPERIDONE PALMITATE | 117MG/0.75ML (117MG/0.75ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 2021-07-06 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A211149-004 | PALIPERIDONE PALMITATE | 156MG/ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 2021-07-06 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A211149-005 | PALIPERIDONE PALMITATE | 234MG/1.5ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 2021-07-06 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A211149-001 | PALIPERIDONE PALMITATE | 39MG/0.25ML (39MG/0.25ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 2021-07-06 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A211149-002 | PALIPERIDONE PALMITATE | 78MG/0.5ML (78MG/0.5ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 2021-07-06 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A211149-003 | PALIPERIDONE PALMITATE | 117MG/0.75ML (117MG/0.75ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 2021-07-06 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A211149-004 | PALIPERIDONE PALMITATE | 156MG/ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 2021-07-06 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A211149-005 | PALIPERIDONE PALMITATE | 234MG/1.5ML (156MG/ML) | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 2021-07-06 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-08-23 18:47 UTC | 2025-08 | A211149-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211149-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211149-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211149-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211149-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211149-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211149-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211149-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211149-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211149-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211149-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211149-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211149-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211149-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211149-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211149-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211149-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211149-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211149-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211149-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211149-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211149-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211149-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211149-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211149-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211149-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211149-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211149-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211149-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211149-005 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211149-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211149-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211149-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211149-004 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211149-005 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A211149-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A211149-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A211149-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A211149-004 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A211149-005 | AB | 1 | d06236e962d9… |
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 |
|---|---|---|---|---|---|---|
| Erzofri extended-release | PALIPERIDONE PALMITATE | Shandong Luye Pharmaceutical Co., Ltd. | 492bf9dd-868e-421a-92db-8cca8973aac1 | 2026-03-09 | Boxed warning, Warnings, Adverse reactions | PALIPERIDONE PALMITATE |
| INVEGA HAFYERA | PALIPERIDONE PALMITATE | Janssen Pharmaceuticals, Inc | 6cd61892-d2cb-434d-83ed-5c1b2c4e7a0b | 2025-02-18 | Boxed warning, Warnings, Adverse reactions | PALIPERIDONE PALMITATE |
| INVEGA SUSTENNA | PALIPERIDONE PALMITATE | Janssen Pharmaceuticals, Inc. | 1af14e42-951d-414d-8564-5d5fce138554 | 2025-02-14 | Boxed warning, Warnings, Adverse reactions | PALIPERIDONE PALMITATE |
| INVEGA TRINZA | PALIPERIDONE PALMITATE | Janssen Pharmaceuticals, Inc | c39e65d7-fa44-4e4c-8b12-a654d3ed0eae | 2025-02-14 | Boxed warning, Warnings, Adverse reactions | PALIPERIDONE PALMITATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 68379 | ORIG | 2021-08-16 |