Application 050754
- Type
- NDA
- Sponsor
- NEOPHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMOXIL | AMOXICILLIN | TABLET;ORAL | 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | AMOXIL | AMOXICILLIN | TABLET;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| N050754-001 | AMOXIL | AMOXICILLIN | 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | |
| N050754-002 | AMOXIL | AMOXICILLIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 |
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| 2026-08 | N050754-001 | AMOXIL | 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N050754-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N050754-001 | AMOXIL | 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N050754-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050754-001 | AMOXIL | 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050754-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050754-001 | AMOXIL | 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050754-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050754-001 | AMOXIL | 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050754-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050754-001 | AMOXIL | 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050754-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050754-001 | AMOXIL | 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050754-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050754-001 | AMOXIL | 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050754-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050754-001 | AMOXIL | 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050754-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050754-001 | AMOXIL | 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050754-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050754-001 | AMOXIL | 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050754-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050754-001 | AMOXIL | 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050754-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050754-001 | AMOXIL | 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050754-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050754-001 | AMOXIL | 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050754-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050754-001 | AMOXIL | 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050754-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N050754-001 | AMOXIL | 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N050754-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050754-001 | AMOXIL | 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050754-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N050754-001 | AMOXIL | 875MG | TABLET / ORAL | RLD | 1998-07-10 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N050754-002 | AMOXIL | 500MG | TABLET / ORAL | RLD | 1998-07-10 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N050754-001 | AMOXIL | 875MG | TABLET / ORAL | RLD | 1998-07-10 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N050754-002 | AMOXIL | 500MG | TABLET / ORAL | RLD | 1998-07-10 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N050754-001 | AMOXIL | 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1998-07-10 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N050754-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1998-07-10 | 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 | 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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50436-4543 | AMOXICILLIN | amoxicillin | Unit Dose Services | NDA | Current |
| 61919-017 | AMOXICILLIN | AMOXICILLIN | Direct Rx | NDA | Current |
| 63187-013 | AMOXICILLIN | amoxicillin | Proficient Rx LP | NDA | Current |
| 63187-013 | AMOXICILLIN | amoxicillin | Proficient Rx LP | NDA | Current |
| 64205-219 | AMOXICILLIN | amoxicillin | ReadyMeds | NDA | Current |
| 64205-224 | AMOXICILLIN | amoxicillin | ReadyMeds | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 78360 | SUPPL | 2024-05-02 |
| 78348 | SUPPL | 2024-05-01 |
| 72562 | SUPPL | 2022-11-04 |
| 72554 | SUPPL | 2022-11-03 |
| 39258 | SUPPL | 2015-12-08 |
| 8195 | SUPPL | 2015-12-08 |
| 39257 | SUPPL | 2015-09-29 |
| 30454 | SUPPL | 2015-09-28 |
| 39256 | SUPPL | 2011-11-21 |
| 30453 | SUPPL | 2011-11-21 |
| 18182 | SUPPL | 2011-11-21 |
| 18181 | SUPPL | 2011-11-21 |
| 8194 | SUPPL | 2011-11-21 |
| 8193 | SUPPL | 2011-11-21 |
| 8191 | SUPPL | 2008-06-13 |
| 18180 | SUPPL | 2008-06-12 |
| 8192 | SUPPL | 2008-04-02 |
| 39255 | SUPPL | 2008-04-01 |
| 42717 | SUPPL | 2004-09-09 |
| 42716 | SUPPL | 2004-09-09 |
| 30452 | SUPPL | 2004-07-21 |
| 22220 | ORIG | 2004-05-27 |
| 8188 | SUPPL | 2004-05-27 |
| 8190 | SUPPL | 2003-12-22 |
| 8189 | SUPPL | 2003-06-08 |
| 30451 | ORIG | 1998-07-10 |