Application 050459
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMOXIL | AMOXICILLIN | CAPSULE;ORAL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | AMOXIL | AMOXICILLIN | CAPSULE;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050459-001 | AMOXIL | AMOXICILLIN | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | ||
| N050459-002 | AMOXIL | AMOXICILLIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 |
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| 2026-08 | N050459-001 | AMOXIL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N050459-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050459-001 | AMOXIL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050459-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050459-001 | AMOXIL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050459-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050459-001 | AMOXIL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050459-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N050459-001 | AMOXIL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N050459-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050459-001 | AMOXIL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050459-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050459-001 | AMOXIL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050459-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050459-001 | AMOXIL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050459-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050459-001 | AMOXIL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050459-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050459-001 | AMOXIL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050459-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050459-001 | AMOXIL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050459-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N050459-001 | AMOXIL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N050459-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050459-001 | AMOXIL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050459-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050459-001 | AMOXIL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050459-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050459-001 | AMOXIL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050459-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N050459-001 | AMOXIL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N050459-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050459-001 | AMOXIL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050459-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N050459-001 | AMOXIL | 250MG | CAPSULE / ORAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N050459-002 | AMOXIL | 500MG | CAPSULE / ORAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N050459-001 | AMOXIL | 250MG | CAPSULE / ORAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N050459-002 | AMOXIL | 500MG | CAPSULE / ORAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N050459-001 | AMOXIL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N050459-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 74a2ff9319b5… |
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 | NorthStar Rx LLC | 843f6053-63d9-47d2-81f1-b6aa78a7c20c | 2024-03-02 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Proficient Rx LP | 6a9cfa97-3715-4b75-a1e3-932a34a942d4 | 2024-03-01 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Hikma Pharmaceuticals USA Inc. | c8591c2a-92ef-4432-b19a-bb46063047ee | 2024-02-28 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Rising Pharma Holdings, Inc. | bbe590a0-4196-4885-b679-cc1833af567f | 2024-02-27 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Sandoz Inc | 13bd4214-9b7f-425b-af5f-fc1ddc678230 | 2024-02-22 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 116f655e-e32f-5030-e063-6394a90a64e5 | 2024-02-15 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Hikma Pharmaceuticals USA Inc. | d46f1091-33dc-4f8f-9c34-75dcfedb4b4c | 2024-02-01 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Hikma Pharmaceuticals USA Inc. | 077f4a65-3cfb-4cb1-99f2-e27ffc5939c0 | 2024-02-01 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Aurobindo Pharma Limited | 7e3a4517-1934-4e03-b96b-4ad65ab076c5 | 2024-01-23 | Warnings, Adverse reactions | AMOXICILLIN |
| AMOXICILLIN | AMOXICILLIN | DIRECT RX | 0173e9de-a995-4386-bb65-8fc2bbf347f9 | 2024-01-09 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Proficient Rx LP | 66404ced-5ef4-4a31-9276-8c6f86add61c | 2024-01-01 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Proficient Rx LP | fcdaba34-373f-4d4e-8203-76f02e3bb00a | 2024-01-01 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 00fbd46e-05fd-4f8a-9f59-a7a4d01c8e54 | 2023-12-18 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | cef5b1ae-8454-4e7a-8830-dd5d601c1d21 | 2023-12-09 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | ca2886d0-7be7-4d41-bad5-df3ad44e0e7e | 2023-12-09 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 4eee2b38-ca84-421d-87e1-031bc5a3f3a7 | 2023-11-24 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 8bac30bb-1dbc-41de-ad50-0a1883f96198 | 2023-11-17 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 156ef8e9-b6e4-4512-865f-7139c90c8f9b | 2023-09-10 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Proficient Rx LP | 2c395111-c9c1-483e-a542-58b935ede689 | 2023-08-01 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Asclemed USA, Inc. | bfd67724-fb22-4eac-8ebd-555614c16329 | 2023-06-17 | Warnings, Adverse reactions | AMOXICILLIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.