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 |
|---|---|---|---|---|---|---|---|---|---|
| 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… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | BX | 2020-06-25 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | BX | 2020-06-25 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | AB | 2020-06-25 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | AB | 2020-06-25 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | AB | 2020-06-25 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | AB | 2020-06-25 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | AB | 2020-06-25 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | AB | 2020-06-25 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | AB | 2020-06-25 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | AB | 2020-06-25 | c0c555d07b60… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A205274-001 | AMOXICILLIN | 125MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A205274-002 | AMOXICILLIN | 250MG | TABLET, CHEWABLE / ORAL | 2020-06-25 | a50c72e98297… |
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 | REMEDYREPACK INC. | 4adc198e-39d8-4b3e-bfa4-278aaf4064ae | 2026-09-09 | Warnings, Adverse reactions | AMOXICILLIN AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | REMEDYREPACK INC. | b6ea2f81-aee6-4c88-b681-50eb28e80a86 | 2026-09-03 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Redpharm Drug | 5a79669f-52f7-e8ea-e063-6394a90a93b8 | 2026-09-02 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | REMEDYREPACK INC. | f37eb415-77b2-41b0-8d20-64e821e4b05d | 2026-09-02 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| AMOXICILLIN | AMOXICILLIN | Redpharm Drug | 5a660370-9a81-33f9-e063-6394a90a6c62 | 2026-09-01 | Warnings, Adverse reactions | AMOXICILLIN AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Sportpharm LLC | c4d4aeca-f63c-4548-a9b7-7f627e8fd45c | 2026-08-29 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | REMEDYREPACK INC. | 82c0c5d1-df2d-4352-bd12-99f955af569e | 2026-08-20 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | REMEDYREPACK INC. | 3a4afd36-dffa-44a1-9d09-e93cf66053bf | 2026-08-20 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 452eb254-028a-4e02-9cb0-85483a4abaf5 | 2026-08-10 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | REMEDYREPACK INC. | afb4149a-0714-4a85-b9e8-2379a8e6a302 | 2026-08-06 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Coupler LLC | 5827b6de-6b48-d73a-e063-6394a90a4a72 | 2026-08-03 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 8cb987bf-d45a-c15a-e053-2995a90aad46 | 2026-08-03 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Redpharm Drug | 57f5652d-ee50-eb7e-e063-6394a90a7b66 | 2026-08-01 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Redpharm Drug | 57e56202-950b-10f6-e063-6394a90a4912 | 2026-07-31 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals, Inc. | 4a402dba-c255-5db8-e054-00144ff8d46c | 2026-07-24 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | REMEDYREPACK INC. | a2c91cf0-a4e4-44c0-b712-bee63dd6c22b | 2026-07-22 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | REMEDYREPACK INC. | 102c62ca-da20-4866-84a8-e3513824af4a | 2026-07-21 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | REMEDYREPACK INC. | 9618d038-e880-47f6-b8d7-bbf8ab35364d | 2026-07-21 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | HAWAII REPACK, INC. | bf130964-8386-4ab7-8d3b-fb0174670afc | 2026-07-17 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | PD-Rx Pharmaceuticals, Inc. | 18a4f555-a537-4c40-9bb2-dc3bd782fa27 | 2026-07-17 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.