Application 202666
- Type
- ANDA
- Sponsor
- TWI PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEXLANSOPRAZOLE | DEXLANSOPRAZOLE | CAPSULE, DELAYED RELEASE;ORAL | 30MG | No | No |
| 002 | DEXLANSOPRAZOLE | DEXLANSOPRAZOLE | CAPSULE, DELAYED RELEASE;ORAL | 60MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202666-001 | DEXLANSOPRAZOLE | DEXLANSOPRAZOLE | 30MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | |
| A202666-002 | DEXLANSOPRAZOLE | DEXLANSOPRAZOLE | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202666-001 | AB |
| A202666-002 | 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 | A202666-001 | DEXLANSOPRAZOLE | 30MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A202666-002 | DEXLANSOPRAZOLE | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A202666-001 | DEXLANSOPRAZOLE | 30MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202666-002 | DEXLANSOPRAZOLE | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202666-001 | DEXLANSOPRAZOLE | 30MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202666-002 | DEXLANSOPRAZOLE | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202666-001 | DEXLANSOPRAZOLE | 30MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202666-002 | DEXLANSOPRAZOLE | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202666-001 | DEXLANSOPRAZOLE | 30MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202666-002 | DEXLANSOPRAZOLE | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202666-001 | DEXLANSOPRAZOLE | 30MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202666-002 | DEXLANSOPRAZOLE | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202666-001 | DEXLANSOPRAZOLE | 30MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202666-002 | DEXLANSOPRAZOLE | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202666-001 | DEXLANSOPRAZOLE | 30MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202666-002 | DEXLANSOPRAZOLE | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202666-001 | DEXLANSOPRAZOLE | 30MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202666-002 | DEXLANSOPRAZOLE | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202666-001 | DEXLANSOPRAZOLE | 30MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202666-002 | DEXLANSOPRAZOLE | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202666-001 | DEXLANSOPRAZOLE | 30MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202666-002 | DEXLANSOPRAZOLE | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202666-001 | DEXLANSOPRAZOLE | 30MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202666-002 | DEXLANSOPRAZOLE | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202666-001 | DEXLANSOPRAZOLE | 30MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202666-002 | DEXLANSOPRAZOLE | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202666-001 | DEXLANSOPRAZOLE | 30MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202666-002 | DEXLANSOPRAZOLE | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202666-001 | DEXLANSOPRAZOLE | 30MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202666-002 | DEXLANSOPRAZOLE | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A202666-001 | DEXLANSOPRAZOLE | 30MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A202666-002 | DEXLANSOPRAZOLE | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A202666-001 | DEXLANSOPRAZOLE | 30MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A202666-002 | DEXLANSOPRAZOLE | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A202666-001 | DEXLANSOPRAZOLE | 30MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | A202666-002 | DEXLANSOPRAZOLE | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A202666-001 | DEXLANSOPRAZOLE | 30MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | A202666-002 | DEXLANSOPRAZOLE | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A202666-001 | DEXLANSOPRAZOLE | 30MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A202666-002 | DEXLANSOPRAZOLE | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | 2022-09-16 | a72a2bbeb626… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A202666-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A202666-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A202666-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202666-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A202666-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202666-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202666-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202666-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202666-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202666-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202666-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202666-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202666-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202666-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202666-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202666-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202666-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202666-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202666-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202666-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202666-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202666-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A202666-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202666-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202666-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202666-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202666-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202666-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202666-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202666-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A202666-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A202666-002 | AB | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A202666-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A202666-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A202666-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A202666-002 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A202666-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A202666-002 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A202666-001 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A202666-002 | AB | 1 | a72a2bbeb626… |
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 |
|---|---|---|---|---|---|---|
| Dexlansoprazole delayed release | DEXLANSOPRAZOLE | Aphena Pharma Solutions - Tennessee, LLC | 59e0c5d7-12e9-b5d7-e063-6394a90a7366 | 2026-08-25 | Warnings, Adverse reactions | 202666 ANDA202666 |
| Dexlansoprazole delayed release | DEXLANSOPRAZOLE | Golden State Medical Supply, Inc. | f799b9b6-ba79-f335-e053-6294a90aaa68 | 2026-06-17 | Warnings, Adverse reactions | 202666 ANDA202666 |
| Dexlansoprazole delayed release | DEXLANSOPRAZOLE | Bryant Ranch Prepack | dcfe880a-b96d-4a3c-aa21-3998d0bcfe9e | 2026-06-16 | Warnings, Adverse reactions | 202666 ANDA202666 |
| Dexlansoprazole delayed release | DEXLANSOPRAZOLE | Upsher-Smith Laboratories, LLC | 8dca4887-c75a-4021-8564-b704e9e1fa3e | 2026-05-08 | Warnings, Adverse reactions | 202666 ANDA202666 24979-001 24979-002 |
| Dexlansoprazole delayed release | DEXLANSOPRAZOLE | Bryant Ranch Prepack | 31d3d485-5f87-4405-b940-490fa4ccf9cc | 2026-02-09 | Warnings, Adverse reactions | 202666 ANDA202666 |
| Dexlansoprazole delayed release | DEXLANSOPRAZOLE | A-S Medication Solutions | 4f44e84f-6219-4445-a67d-df37d18b014d | 2023-06-06 | Warnings, Adverse reactions | 202666 ANDA202666 |