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001 | AMOXIL | AMOXICILLIN | TABLET;ORAL | 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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002 | AMOXIL | AMOXICILLIN | TABLET;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| N050754-001 | AMOXIL | AMOXICILLIN | 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | |
| N050754-002 | AMOXIL | AMOXICILLIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 |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| 2026-08 | N050754-001 | AMOXIL | 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | 84e616aacf4f… | |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| 2026-08 | N050754-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | 84e616aacf4f… | |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| 2026-07 | N050754-001 | AMOXIL | 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | caaa826d4ba7… | |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. | 3e4f0f03-438b-ddfb-e063-6294a90adb38 | 2025-09-08 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Preferred Pharmaceuticals Inc. | 9cad7ff5-5151-47d9-bc66-2ded25deefc2 | 2025-09-05 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Redpharm Drug | 3d0025b4-b7bb-69db-e063-6294a90a0e70 | 2025-08-23 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | PD-Rx Pharmaceuticals, Inc. | 09660a95-a7b3-4d1f-832c-a4fa7a5b7ddd | 2025-07-17 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | fd071263-b750-4831-9fc5-de112a5f685b | 2025-06-27 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 3880b9c2-62a5-0d23-e063-6394a90a1252 | 2025-06-26 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | b988349d-2198-4dbb-a231-9ba37262ce28 | 2025-06-23 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 364f969d-3037-4dff-b04b-304bca27442e | 2025-06-23 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 521f7a05-4e6d-447f-b38e-00c4d623703b | 2025-06-23 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Bryant Ranch Prepack | 1c755ad7-f0a8-4a63-a686-413bae57f8d0 | 2025-06-20 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Bryant Ranch Prepack | 5d0132d0-1d5a-46d0-bc62-76d62a7bd19d | 2025-06-03 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Bryant Ranch Prepack | c0343d5e-96b2-46fa-bf54-e2ffa0c90b41 | 2025-06-03 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Bryant Ranch Prepack | 95eaa9ac-c64a-4f1d-b5a3-66489d5b1edb | 2025-06-03 | Warnings, Adverse reactions | AMOXICILLIN |
| AMOXICILLIN | AMOXICILLIN | USAntibiotics, LLC | 110ba6b1-f175-48a1-8e30-616c02212538 | 2025-06-01 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceutials,Inc. | 1f818d89-be59-b43d-e063-6394a90a12c3 | 2025-05-28 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | b91f40dd-40db-473d-a399-166aeb1ce7e2 | 2025-05-15 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | PD-Rx Pharmaceuticals, Inc. | d37f2e3c-01f0-4a81-a46f-1615b82e2499 | 2025-04-17 | Warnings, Adverse reactions | AMOXICILLIN |
| AMOXICILLIN | AMOXICILLIN | Redpharm Drug | 0a100e76-513c-98d3-e063-6294a90adf47 | 2025-04-09 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | e58a65d7-d813-446d-b70b-7465809a5d2c | 2025-04-09 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 641ec2a8-368a-4c5c-8c11-37366a06ce93 | 2025-04-08 | 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 |