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001 | AMOXIL | AMOXICILLIN | TABLET;ORAL | 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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002 | AMOXIL | AMOXICILLIN | TABLET;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| N050754-001 | AMOXIL | AMOXICILLIN | 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | |
| N050754-002 | AMOXIL | AMOXICILLIN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 |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| 2026-08 | N050754-001 | AMOXIL | 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | 84e616aacf4f… | |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| 2026-08 | N050754-002 | AMOXIL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | 84e616aacf4f… | |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| 2026-07 | N050754-001 | AMOXIL | 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1998-07-10 | caaa826d4ba7… | |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 | A-S Medication Solutions | 9d56f34f-c025-4e97-8f5e-4d93f1ab0055 | 2025-04-08 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 4b15c5b4-460c-449f-9e48-99870b382826 | 2025-04-02 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Proficient Rx LP | 577d8a00-c538-4089-b788-01b4b92d22f2 | 2025-04-01 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 54c1d2a4-fe96-6efb-e054-00144ff88e88 | 2025-03-31 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Preferred Pharmaceuticals Inc. | 992d7829-34d1-4c88-8a5c-1a92d001d194 | 2025-03-24 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals, Inc. | 3d6cf1b3-f1dc-4eab-e054-00144ff88e88 | 2025-03-10 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | American Health Packaging | ecb439f7-434a-4e4c-b899-943d83346f09 | 2025-03-03 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | cf707c13-3b40-079c-e053-2995a90a2176 | 2025-02-10 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 80a04b8a-110e-0aea-e053-2a91aa0ad057 | 2025-02-06 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals, Inc. | 4f1c940c-9f17-4289-e054-00144ff88e88 | 2025-02-04 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | PD-Rx Pharmaceuticals, Inc. | 05b9b595-05d9-469f-82a3-c2bc94c50be2 | 2025-01-30 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Redpharm Drug | fc61c9f5-b0f8-3ff8-e053-6394a90adeb7 | 2025-01-23 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxil | AMOXICILLIN ORAL SUSP | DirectRx | ec7dd735-dc92-3d29-e053-2a95a90af549 | 2025-01-22 | Warnings, Adverse reactions | Amoxil |
| Amoxicillin | AMOXICILLIN | Direct_Rx | f98c49a3-e6bb-7fc7-e053-6394a90a9062 | 2025-01-22 | Warnings, Adverse reactions | AMOXICILLIN |
| AMOXICILLIN | AMOXICILLIN | DirectRx | cedde8f5-aadd-53de-e053-2995a90aab16 | 2025-01-20 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 6d7143e3-6a82-3613-e053-2a91aa0a8f65 | 2025-01-08 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 5b2a2e62-6fd2-4ab1-b936-8702e68233fa | 2025-01-08 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Preferred Pharmaceuticals Inc. | c84082fc-ea07-4e73-99c5-8356b957a1c5 | 2025-01-03 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Northwind Pharmaceuticals, LLC | 26114563-c719-46da-b976-3e4271533f28 | 2025-01-02 | Warnings, Adverse reactions | AMOXICILLIN |
| Amoxicillin | AMOXICILLIN | Advanced Rx Pharmacy of Tennessee, LLC | f4c36acc-828d-323b-e053-2a95a90a4d1c | 2024-12-31 | 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 |