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 | Preferred Pharmaceuticals Inc. | 0ce05282-995c-461e-b807-facb1fcbb405 | 2026-01-19 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| AMOXICILLIN | AMOXICILLIN | Chartwell RX, LLC | 9ce26893-c7a1-47e9-98f9-f5d998cac418 | 2025-12-22 | Warnings, Adverse reactions | AMOXICILLIN AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Chartwell RX, LLC | 1b9c0a98-2a31-4b23-ac4f-7c3f14b6f92f | 2025-12-22 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Chartwell RX, LLC | 5002cce4-0abc-4446-888c-47396549d4da | 2025-12-22 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Chartwell Governmental & Specialty RX, LLC | f9062321-ffb3-42e8-8f98-453cd30f5282 | 2025-12-22 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | QPharma, Inc. | 7f40b439-d826-4a19-b184-702e9bd5a883 | 2025-12-19 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin 500 mg | AMOXICILLIN | Health Department, Oklahoma State | f049551b-4708-eb13-e053-2a95a90afd1f | 2025-12-13 | AMOXICILLIN | |
| Amoxicillin | AMOXICILLIN | ASCLEMED USA INC. | 08100595-e6de-4a8a-a177-a94f849bbe9f | 2025-12-10 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Asclemed USA, Inc. | 32b224c2-1354-4b58-b082-b93330e6962b | 2025-12-10 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | QPharma, Inc. | 2700df91-c5ef-4931-9ad7-a3c1c146ccac | 2025-12-09 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | QPharma Inc | 2772a745-1276-405b-b229-95edf5534b2a | 2025-12-05 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals, Inc. | 4528f48d-5bda-b307-e063-6294a90a294c | 2025-12-04 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 8e6f9df1-0754-69e4-e053-2a95a90acc49 | 2025-12-02 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 071086f5-e4ed-b1d9-e063-6294a90ad304 | 2025-11-13 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Bryant Ranch Prepack | bbaeb509-ad04-4668-a1db-4358038893f2 | 2025-10-23 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | PD-Rx Pharmaceuticals, Inc. | 039d2677-b04f-436c-e063-6294a90ac519 | 2025-10-20 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | PD-Rx Pharmaceuticals, Inc. | d0938df9-9065-47eb-9eae-0722ed1411a1 | 2025-10-17 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | PD-Rx Pharmaceuticals, Inc. | 987786a1-d748-4b42-abb5-62a2f38ef195 | 2025-10-17 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | PD-Rx Pharmaceuticals, Inc. | 98e9274c-c02e-44d9-8cc5-17536ef03a77 | 2025-10-10 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | PD-Rx Pharmaceuticals, Inc. | b397d4be-d2ef-419a-98ac-844069c99d56 | 2025-10-08 | Warnings, Adverse reactions | Amoxicillin AMOXICILLIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.