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001 | AMOXIL | AMOXICILLIN | TABLET;ORAL | 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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002 | AMOXIL | AMOXICILLIN | TABLET;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| N050754-001 | AMOXIL | AMOXICILLIN | 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | |
| N050754-002 | AMOXIL | AMOXICILLIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 |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| 2026-08 | N050754-001 | AMOXIL | 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | 84e616aacf4f… | |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| 2026-08 | N050754-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | 84e616aacf4f… | |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| 2026-07 | N050754-001 | AMOXIL | 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | caaa826d4ba7… | |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. | 6e9bf369-2f96-c7ae-e053-2a91aa0a715f | 2024-06-10 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 7524da98-b0a5-3db8-e053-2a91aa0a6ff1 | 2024-06-10 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Aurobindo Pharma Limited | 234d0dfc-cb24-413f-b798-129c73eb848e | 2024-06-04 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Bryant Ranch Prepack | 7b182161-128e-430c-98b2-592c242ba711 | 2024-05-30 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Bryant Ranch Prepack | 260a3a79-9dd6-4c4b-82ec-f8050346e886 | 2024-05-30 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Bryant Ranch Prepack | aee851cf-428e-4d29-a281-078fe00c56b0 | 2024-05-30 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Bryant Ranch Prepack | 9925773d-8ea1-4193-91e3-52cc1ce5ca67 | 2024-05-30 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Teva Pharmaceuticals USA, Inc. | 4c0f348a-a65d-409c-8668-207c82a5e3cb | 2024-05-22 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 14a5f8c2-fdaf-4ad4-982b-c5aa128e242d | 2024-05-06 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 7db086c6-a56b-4848-9eec-abaaff9f5b6f | 2024-05-01 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | d5ecb620-5267-4dcf-be81-64c7766516f5 | 2024-05-01 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | a2a5bb34-671b-499c-b8b4-c40fb51af09a | 2024-04-30 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 3d8a700b-b23b-459a-a19a-213dd39b6a3a | 2024-04-30 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | efc66d77-1733-41e1-9aed-7c10a4b4ba96 | 2024-04-30 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 6a3d1af5-6e93-4f06-8d82-1c87290c46aa | 2024-04-30 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 1dc5cc5a-59ba-4bc9-b581-cb7b70ce2652 | 2024-04-30 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 322feb95-8bd4-440a-bda2-29ee19b11234 | 2024-04-15 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 4d0f063a-d896-4757-8f22-9614e2ad71d4 | 2024-04-11 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 73219f24-6eac-4472-b2a7-cad36936c185 | 2024-04-11 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 26202694-cf20-4b08-90cc-70a3d30cbb0f | 2024-04-11 | 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 |