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 | 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 |
| Amoxicillin | AMOXICILLIN | Preferred Pharmaceuticals Inc. | ad804b34-169c-44bf-a469-f1149433d96b | 2026-07-15 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | PD-Rx Pharmaceuticals, Inc. | 96057ce7-9516-4239-9974-5e9691b44c9b | 2026-07-09 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Northwind Health Company, LLC | 1d0d8bc4-137e-ef10-e063-6294a90acf62 | 2026-07-09 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Northwind Health Company, LLC | 26e257d5-5b98-3795-e063-6394a90a05bc | 2026-07-09 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Northwind Health Company, LLC | 4ecefd37-9847-1d93-e063-6394a90a19f0 | 2026-07-09 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | USAntibiotics, LLC | 06e5c07d-d95c-4955-8d35-a4703ca2359e | 2026-07-07 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | HAWAII REPACK, INC. | 669a243e-249d-4ccb-9693-66de073e53bb | 2026-07-03 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | REMEDYREPACK INC. | 53548597-347b-42a9-916c-e88cd27b8dcd | 2026-07-01 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 60c7ae87-9631-4b29-9ca4-82fb3bafcab8 | 2026-06-22 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Proficient Rx LP | 313ea909-5b1b-41ff-a0db-5aadc12e2e4f | 2026-06-01 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Proficient Rx LP | ef03286b-4ba7-4952-9ab1-90cacf300504 | 2026-06-01 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Coupler LLC | 52bd03c6-528a-c443-e063-6394a90aad39 | 2026-05-26 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 5155ca5d-fe58-42b4-e063-6394a90ab135 | 2026-05-21 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Bryant Ranch Prepack | be7d8459-b8e6-499a-ab87-99bd17492525 | 2026-05-08 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | QPharma, Inc | 60c788d1-6c91-4456-848a-893e649e90be | 2026-05-08 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | QPharma Inc | ddd1307d-3216-0e59-e053-2995a90ad19d | 2026-05-08 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Coupler LLC | 50fff2b8-8bf1-ff46-e063-6394a90a9213 | 2026-05-04 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Coupler LLC | 5037e2a5-52e9-caec-e063-6294a90ad837 | 2026-04-28 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.