Application 065256
- Type
- ANDA
- Sponsor
- AUROBINDO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMOXICILLIN | AMOXICILLIN | TABLET;ORAL | 500MG | No | No |
| 002 | AMOXICILLIN | AMOXICILLIN | TABLET;ORAL | 875MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A065256-001 | AMOXICILLIN | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | |
| A065256-002 | AMOXICILLIN | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A065256-001 | AB |
| A065256-002 | 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 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065256-001 | AMOXICILLIN | 500MG | TABLET / ORAL | AB | 2005-11-09 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065256-002 | AMOXICILLIN | 875MG | TABLET / ORAL | AB | 2005-11-09 | 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 | A065256-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A065256-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A065256-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A065256-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A065256-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A065256-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065256-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065256-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A065256-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A065256-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065256-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065256-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065256-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065256-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065256-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065256-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065256-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065256-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065256-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065256-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065256-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065256-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A065256-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A065256-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065256-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065256-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065256-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065256-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065256-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065256-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A065256-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A065256-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065256-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065256-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A065256-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A065256-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A065256-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A065256-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A065256-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A065256-002 | AB | 1 | 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 | Rising Pharma Holdings, Inc. | bb7733f8-6aad-4273-84a0-ef472630203f | 2024-07-07 | Warnings, Adverse reactions | 065256 ANDA065256 57237-028 57237-029 |
| Amoxicillin | AMOXICILLIN | Aurobindo Pharma Limited | 99103779-6d2f-4e4b-9b7f-0b24d7c6bf4e | 2024-06-20 | Warnings, Adverse reactions | 065256 ANDA065256 65862-014 65862-015 |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 00fbd46e-05fd-4f8a-9f59-a7a4d01c8e54 | 2023-12-18 | Warnings, Adverse reactions | 065256 ANDA065256 50090-0714 |
| Amoxicillin | AMOXICILLIN | Proficient Rx LP | 586a5911-e30b-40ed-a056-9e67920ca951 | 2019-11-01 | Warnings, Adverse reactions | 065256 ANDA065256 63187-729 |
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 |
|---|---|---|---|---|---|
| 10544-950 | Amoxicillin | Amoxicillin | Blenheim Pharmacal, Inc. | ANDA | Current |
| 12634-874 | Amoxicillin | Amoxicillin | Apotheca Inc. | ANDA | Current |
| 33261-488 | Amoxicillin | Amoxicillin | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 42708-078 | Amoxicillin | Amoxicillin | QPharma Inc | ANDA | Current |
| 42708-078 | Amoxicillin | Amoxicillin | QPharma Inc | ANDA | Current |
| 50090-0709 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50090-0709 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50090-0713 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50090-0713 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50090-0713 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50090-0714 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50090-0714 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50090-1595 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50090-1595 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50090-1596 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50090-1825 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50090-1825 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50090-1825 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50436-0029 | Amoxicillin | Amoxicillin | Unit Dose Services | ANDA | Current |
| 53002-0130 | Amoxicillin | Amoxicillin | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-0130 | Amoxicillin | Amoxicillin | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53217-210 | Amoxicillin | Amoxicillin | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 57237-028 | Amoxicillin | Amoxicillin | Rising Health, LLC | ANDA | Current |
| 57237-028 | Amoxicillin | Amoxicillin | Rising Health, LLC | ANDA | Current |
| 57237-028 | Amoxicillin | Amoxicillin | Rising Health, LLC | ANDA | Current |
| 57237-028 | Amoxicillin | Amoxicillin | Rising Health, LLC | ANDA | Current |
| 57237-029 | Amoxicillin | Amoxicillin | Rising Health, LLC | ANDA | Current |
| 57237-029 | Amoxicillin | Amoxicillin | Rising Health, LLC | ANDA | Current |
| 57237-029 | Amoxicillin | Amoxicillin | Rising Health, LLC | ANDA | Current |
| 57237-029 | Amoxicillin | Amoxicillin | Rising Health, LLC | ANDA | Current |
| 61919-135 | AMOXIL | AMOXICILLIN | DIRECT RX | ANDA | Current |
| 61919-135 | AMOXIL | AMOXICILLIN | DIRECT RX | ANDA | Current |
| 61919-135 | AMOXIL | AMOXICILLIN | DIRECT RX | ANDA | Current |
| 61919-366 | AMOXICILLIN | amoxicillin tablet, film coated | Direct RX | ANDA | Current |
| 61919-623 | AMOXICILLIN | AMOXICILLIN | DIRECT RX | ANDA | Current |
| 61919-623 | AMOXICILLIN | AMOXICILLIN | DIRECT RX | ANDA | Current |
| 63187-325 | Amoxicillin | Amoxicillin | Proficient Rx LP | ANDA | Current |
| 63187-325 | Amoxicillin | Amoxicillin | Proficient Rx LP | ANDA | Current |
| 63187-325 | Amoxicillin | Amoxicillin | Proficient Rx LP | ANDA | Current |
| 63187-729 | Amoxicillin | Amoxicillin | Proficient Rx LP | ANDA | Current |
| 63187-729 | Amoxicillin | Amoxicillin | Proficient Rx LP | ANDA | Current |
| 65862-014 | Amoxicillin | Amoxicillin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-014 | Amoxicillin | Amoxicillin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-014 | Amoxicillin | Amoxicillin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-014 | Amoxicillin | Amoxicillin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-015 | Amoxicillin | Amoxicillin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-015 | Amoxicillin | Amoxicillin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-015 | Amoxicillin | Amoxicillin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-015 | Amoxicillin | Amoxicillin | Aurobindo Pharma Limited | ANDA | Current |
| 66116-477 | Amoxicillin | Amoxicillin | MedVantx, Inc. | ANDA | Current |
| 66267-549 | Amoxicillin | Amoxicillin | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-549 | Amoxicillin | Amoxicillin | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 67296-0627 | Amoxicillin | Amoxicillin | RedPharm Drug Inc. | ANDA | Current |
| 67296-1126 | Amoxicillin | Amoxicillin | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1126 | Amoxicillin | Amoxicillin | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1126 | Amoxicillin | Amoxicillin | RedPharm Drug, Inc. | ANDA | Current |
| 68071-2911 | Amoxicillin | Amoxicillin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3343 | Amoxicillin | Amoxicillin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3343 | Amoxicillin | Amoxicillin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4086 | Amoxicillin | Amoxicillin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4086 | Amoxicillin | Amoxicillin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4982 | Amoxicillin | Amoxicillin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4982 | Amoxicillin | Amoxicillin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5096 | Amoxicillin | Amoxicillin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5096 | Amoxicillin | Amoxicillin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7414 | Amoxicillin | Amoxicillin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7414 | Amoxicillin | Amoxicillin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7414 | Amoxicillin | Amoxicillin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8977 | Amoxicillin | Amoxicillin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-1008 | Amoxicillin | Amoxicillin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1008 | Amoxicillin | Amoxicillin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1093 | Amoxicillin | Amoxicillin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1093 | Amoxicillin | Amoxicillin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1438 | Amoxicillin | Amoxicillin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1438 | Amoxicillin | Amoxicillin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2191 | Amoxicillin | Amoxicillin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2191 | Amoxicillin | Amoxicillin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2191 | Amoxicillin | Amoxicillin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2191 | Amoxicillin | Amoxicillin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2191 | Amoxicillin | Amoxicillin | REMEDYREPACK INC. | ANDA | Current |