Application 205274
- Type
- ANDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMOXICILLIN | AMOXICILLIN | TABLET, CHEWABLE;ORAL | 125MG | No | No |
| 002 | AMOXICILLIN | AMOXICILLIN | TABLET, CHEWABLE;ORAL | 250MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A205274-001 | AMOXICILLIN | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | ||
| A205274-002 | AMOXICILLIN | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | 2020-06-25 |
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 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2021-12-28 21:50 UTC | 2021-12 | A205274-001 | BX | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A205274-002 | BX | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A205274-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A205274-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A205274-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A205274-002 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A205274-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A205274-002 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A205274-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A205274-002 | AB | 1 | c0c555d07b60… |
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 |
|---|---|---|---|---|---|---|
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 5c60cb1c-3baf-3af2-e053-2a91aa0ae208 | 2024-12-27 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 59a546ed-84b7-a54a-e053-2991aa0a3a0d | 2024-12-26 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | aaf42367-153e-4525-af5f-f5f1c7d6c559 | 2024-12-24 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Bryant Ranch Prepack | bef50f2a-78c6-4d0c-8ad9-cfa3c801629d | 2024-11-25 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals, Inc. | 26469497-14c2-adb2-e063-6394a90af30a | 2024-11-06 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Asclemed USA, Inc. | a56d7a5e-2b2c-4121-9d9c-a3283b3cebf9 | 2024-11-05 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | e13cafe2-f226-4021-81d8-7bd1f98b5582 | 2024-11-04 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 05e88717-2ce3-4b1a-88af-c3f61a2d8cd5 | 2024-11-04 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 0b5acc3f-c474-4b16-9d66-8048abb3b22d | 2024-11-04 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 5edc5d32-43d5-4418-9832-40363a919edc | 2024-11-04 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 3b5a9e0f-a9d7-40e8-8c36-c91f6ec2e3c6 | 2024-11-04 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 963986fc-0e59-21b0-e053-2a95a90a9531 | 2024-10-10 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | c3d3f94f-e976-4625-9667-3d716932f2fa | 2024-10-09 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| AMOXICILLIN | AMOXICILLIN | Micro Labs Limited | 42f935ca-45ba-4b3e-8b40-9b2d4eb56281 | 2024-10-03 | Warnings, Adverse reactions | AMOXICILLIN AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Proficient Rx LP | 52e676e4-b70e-4e73-bbe7-f54d91ca7e0a | 2024-10-01 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals Inc. | 2177c68d-2884-ce70-e063-6294a90aa267 | 2024-09-06 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals, Inc. | 20eb4ade-f3b8-db66-e063-6294a90ae846 | 2024-08-30 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 85721bc3-37eb-4db6-8a40-8a1412ac953a | 2024-08-23 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Asclemed USA, Inc. | a18751fa-6202-4ae2-950a-a3f1dc9a8afd | 2024-08-21 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Asclemed USA, Inc. | 9cd42f6f-cc7a-43f5-98dd-a5d6210933ae | 2024-08-14 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.