Application 050460
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMOXIL | AMOXICILLIN | FOR SUSPENSION;ORAL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | AMOXIL | AMOXICILLIN | FOR SUSPENSION;ORAL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 005 | AMOXIL | AMOXICILLIN | FOR SUSPENSION;ORAL | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 006 | LAROTID | AMOXICILLIN | FOR SUSPENSION;ORAL | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| N050460-001 | AMOXIL | AMOXICILLIN | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | ||
| N050460-002 | AMOXIL | AMOXICILLIN | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | ||
| N050460-005 | AMOXIL | AMOXICILLIN | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | ||
| N050460-006 | LAROTID | AMOXICILLIN | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 |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 | N050460-001 | AMOXIL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N050460-002 | AMOXIL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N050460-005 | AMOXIL | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N050460-006 | LAROTID | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050460-001 | AMOXIL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050460-002 | AMOXIL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050460-005 | AMOXIL | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050460-006 | LAROTID | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050460-001 | AMOXIL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050460-002 | AMOXIL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050460-005 | AMOXIL | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050460-006 | LAROTID | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050460-001 | AMOXIL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050460-002 | AMOXIL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050460-005 | AMOXIL | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050460-006 | LAROTID | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N050460-001 | AMOXIL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N050460-002 | AMOXIL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N050460-005 | AMOXIL | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N050460-006 | LAROTID | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050460-001 | AMOXIL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050460-002 | AMOXIL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050460-005 | AMOXIL | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050460-006 | LAROTID | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050460-001 | AMOXIL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050460-002 | AMOXIL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050460-005 | AMOXIL | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050460-006 | LAROTID | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050460-001 | AMOXIL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050460-002 | AMOXIL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050460-005 | AMOXIL | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050460-006 | LAROTID | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050460-001 | AMOXIL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050460-002 | AMOXIL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050460-005 | AMOXIL | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050460-006 | LAROTID | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050460-001 | AMOXIL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050460-002 | AMOXIL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050460-005 | AMOXIL | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050460-006 | LAROTID | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… |
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. | 5f8b3c58-ed9f-84a2-e053-2a91aa0ac8cf | 2024-12-27 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 5c60cb1c-3baf-3af2-e053-2a91aa0ae208 | 2024-12-27 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 59a546ed-84b7-a54a-e053-2991aa0a3a0d | 2024-12-26 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | aaf42367-153e-4525-af5f-f5f1c7d6c559 | 2024-12-24 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Bryant Ranch Prepack | bef50f2a-78c6-4d0c-8ad9-cfa3c801629d | 2024-11-25 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals, Inc. | 26469497-14c2-adb2-e063-6394a90af30a | 2024-11-06 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Asclemed USA, Inc. | a56d7a5e-2b2c-4121-9d9c-a3283b3cebf9 | 2024-11-05 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | e13cafe2-f226-4021-81d8-7bd1f98b5582 | 2024-11-04 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 05e88717-2ce3-4b1a-88af-c3f61a2d8cd5 | 2024-11-04 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 0b5acc3f-c474-4b16-9d66-8048abb3b22d | 2024-11-04 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 5edc5d32-43d5-4418-9832-40363a919edc | 2024-11-04 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 3b5a9e0f-a9d7-40e8-8c36-c91f6ec2e3c6 | 2024-11-04 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 963986fc-0e59-21b0-e053-2a95a90a9531 | 2024-10-10 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | c3d3f94f-e976-4625-9667-3d716932f2fa | 2024-10-09 | Warnings, Adverse reactions | AMOXICILLIN |
| AMOXICILLIN | AMOXICILLIN | Micro Labs Limited | 42f935ca-45ba-4b3e-8b40-9b2d4eb56281 | 2024-10-03 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Proficient Rx LP | 52e676e4-b70e-4e73-bbe7-f54d91ca7e0a | 2024-10-01 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals Inc. | 2177c68d-2884-ce70-e063-6294a90aa267 | 2024-09-06 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals, Inc. | 20eb4ade-f3b8-db66-e063-6294a90ae846 | 2024-08-30 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 85721bc3-37eb-4db6-8a40-8a1412ac953a | 2024-08-23 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Asclemed USA, Inc. | a18751fa-6202-4ae2-950a-a3f1dc9a8afd | 2024-08-21 | Warnings, Adverse reactions | AMOXICILLIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.