Application 050760
- Type
- NDA
- Sponsor
- NEOPHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMOXIL | AMOXICILLIN | FOR SUSPENSION;ORAL | 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | AMOXIL | AMOXICILLIN | FOR SUSPENSION;ORAL | 400MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| N050760-001 | AMOXIL | AMOXICILLIN | 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1999-04-15 | |
| N050760-002 | AMOXIL | AMOXICILLIN | 400MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | AB | RLD | 1999-04-15 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N050760-002 | AB |
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| 2026-08 | N050760-001 | AMOXIL | 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1999-04-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N050760-002 | AMOXIL | 400MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | AB | RLD | 1999-04-15 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N050760-001 | AMOXIL | 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1999-04-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N050760-002 | AMOXIL | 400MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | AB | RLD | 1999-04-15 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N050760-001 | AMOXIL | 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1999-04-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050760-002 | AMOXIL | 400MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | AB | RLD | 1999-04-15 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050760-001 | AMOXIL | 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1999-04-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050760-002 | AMOXIL | 400MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | AB | RLD | 1999-04-15 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N050760-001 | AMOXIL | 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1999-04-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050760-002 | AMOXIL | 400MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | AB | RLD | 1999-04-15 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050760-001 | AMOXIL | 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1999-04-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050760-002 | AMOXIL | 400MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | AB | RLD | 1999-04-15 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050760-001 | AMOXIL | 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1999-04-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050760-002 | AMOXIL | 400MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | AB | RLD | 1999-04-15 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050760-001 | AMOXIL | 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1999-04-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050760-002 | AMOXIL | 400MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | AB | RLD | 1999-04-15 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050760-001 | AMOXIL | 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1999-04-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050760-002 | AMOXIL | 400MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | AB | RLD | 1999-04-15 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050760-001 | AMOXIL | 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1999-04-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050760-002 | AMOXIL | 400MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | AB | RLD | 1999-04-15 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050760-001 | AMOXIL | 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1999-04-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050760-002 | AMOXIL | 400MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | AB | RLD | 1999-04-15 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N050760-001 | AMOXIL | 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1999-04-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050760-002 | AMOXIL | 400MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | AB | RLD | 1999-04-15 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050760-001 | AMOXIL | 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1999-04-15 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050760-002 | AMOXIL | 400MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | AB | RLD | 1999-04-15 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050760-001 | AMOXIL | 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1999-04-15 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050760-002 | AMOXIL | 400MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | AB | RLD | 1999-04-15 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050760-001 | AMOXIL | 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1999-04-15 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050760-002 | AMOXIL | 400MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | AB | RLD | 1999-04-15 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N050760-001 | AMOXIL | 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1999-04-15 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N050760-002 | AMOXIL | 400MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | AB | RLD | 1999-04-15 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050760-001 | AMOXIL | 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1999-04-15 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050760-002 | AMOXIL | 400MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1999-04-15 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N050760-001 | AMOXIL | 200MG/5ML | FOR SUSPENSION / ORAL | RLD | 1999-04-15 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N050760-002 | AMOXIL | 400MG/5ML | FOR SUSPENSION / ORAL | RLD | 1999-04-15 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N050760-001 | AMOXIL | 200MG/5ML | FOR SUSPENSION / ORAL | RLD | 1999-04-15 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N050760-002 | AMOXIL | 400MG/5ML | FOR SUSPENSION / ORAL | RLD | 1999-04-15 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N050760-001 | AMOXIL | 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | FOR SUSPENSION / ORAL | RLD | 1999-04-15 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N050760-002 | AMOXIL | 400MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | FOR SUSPENSION / ORAL | RLD | 1999-04-15 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N050760-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N050760-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N050760-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050760-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N050760-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050760-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050760-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050760-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050760-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050760-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050760-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N050760-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050760-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050760-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050760-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N050760-002 | AB | 1 | 8072bd15b7f6… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N050760-002 | AB | 1 | a50c72e98297… |
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 | USAntibiotics, LLC | 06e5c07d-d95c-4955-8d35-a4703ca2359e | 2026-07-07 | Warnings, Adverse reactions | 050760 NDA050760 |
| Amoxicillin | AMOXICILLIN | ASCLEMED USA INC. | 08100595-e6de-4a8a-a177-a94f849bbe9f | 2025-12-10 | Warnings, Adverse reactions | 050760 NDA050760 |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals, Inc. | 4528f48d-5bda-b307-e063-6294a90a294c | 2025-12-04 | Warnings, Adverse reactions | 050760 NDA050760 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
Documents#
| Document | Submission type | Date |
|---|---|---|
| 78361 | SUPPL | 2024-05-02 |
| 78349 | SUPPL | 2024-05-02 |
| 72563 | SUPPL | 2022-11-04 |
| 72555 | SUPPL | 2022-11-03 |
| 39298 | SUPPL | 2015-12-08 |
| 8233 | SUPPL | 2015-12-08 |
| 18205 | SUPPL | 2015-09-29 |
| 8232 | SUPPL | 2015-09-28 |
| 39297 | SUPPL | 2011-11-21 |
| 39296 | SUPPL | 2011-11-21 |
| 30498 | SUPPL | 2011-11-21 |
| 30497 | SUPPL | 2011-11-21 |
| 18204 | SUPPL | 2011-11-21 |
| 8231 | SUPPL | 2011-11-21 |
| 8229 | SUPPL | 2008-06-13 |
| 18203 | SUPPL | 2008-06-12 |
| 8230 | SUPPL | 2008-04-02 |
| 39295 | SUPPL | 2008-04-01 |
| 30496 | SUPPL | 2006-01-30 |
| 39294 | SUPPL | 2006-01-27 |
| 42724 | ORIG | 2005-07-11 |
| 42725 | SUPPL | 2004-09-09 |
| 30495 | SUPPL | 2004-07-21 |
| 30494 | SUPPL | 2003-12-22 |
| 30493 | SUPPL | 2003-06-08 |
| 30492 | ORIG | 1999-04-15 |
| 18202 | ORIG | 1999-04-15 |