Application 065322
- Type
- ANDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMOXICILLIN | AMOXICILLIN | FOR SUSPENSION;ORAL | 250MG/5ML | No | No |
| 002 | AMOXICILLIN | AMOXICILLIN | FOR SUSPENSION;ORAL | 125MG/5ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A065322-001 | AMOXICILLIN | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | |
| A065322-002 | AMOXICILLIN | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A065322-001 | AB |
| A065322-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A065322-001 | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A065322-002 | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065322-001 | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065322-002 | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065322-001 | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065322-002 | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065322-001 | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065322-002 | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065322-001 | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065322-002 | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065322-001 | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065322-002 | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065322-001 | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065322-002 | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065322-001 | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065322-002 | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065322-001 | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065322-002 | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065322-001 | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065322-002 | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065322-001 | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065322-002 | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065322-001 | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065322-002 | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065322-001 | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065322-002 | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A065322-001 | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A065322-002 | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065322-001 | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065322-002 | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A065322-001 | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A065322-002 | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A065322-001 | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A065322-002 | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065322-001 | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065322-002 | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A065322-001 | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A065322-002 | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A065322-001 | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A065322-002 | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION / ORAL | AB | 2006-06-19 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A065322-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A065322-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065322-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065322-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A065322-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A065322-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065322-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065322-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065322-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065322-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065322-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065322-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065322-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065322-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065322-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065322-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065322-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065322-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A065322-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A065322-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065322-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065322-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065322-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065322-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065322-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065322-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A065322-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A065322-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065322-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065322-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A065322-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A065322-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A065322-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A065322-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A065322-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A065322-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A065322-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A065322-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A065322-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A065322-002 | AB | 1 | 782e0a99824c… |
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 | 60c7ae87-9631-4b29-9ca4-82fb3bafcab8 | 2026-06-22 | Warnings, Adverse reactions | 065322 ANDA065322 50090-0404 |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | bd46de4c-4571-ba9a-e053-2a95a90a792d | 2026-02-19 | Warnings, Adverse reactions | 065322 ANDA065322 68071-2364 |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 8bce45db-dea7-4090-9d64-8b11b08d963e | 2026-02-12 | Warnings, Adverse reactions | 065322 ANDA065322 50090-0405 |
| Amoxicillin | AMOXICILLIN | Preferred Pharmaceuticals Inc. | 0ce05282-995c-461e-b807-facb1fcbb405 | 2026-01-19 | Warnings, Adverse reactions | 065322 ANDA065322 |
| Amoxicillin | AMOXICILLIN | Preferred Pharmaceuticals Inc. | 9cad7ff5-5151-47d9-bc66-2ded25deefc2 | 2025-09-05 | Warnings, Adverse reactions | 065322 ANDA065322 |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 54c1d2a4-fe96-6efb-e054-00144ff88e88 | 2025-03-31 | Warnings, Adverse reactions | 065322 ANDA065322 66267-993 |
| Amoxil | AMOXICILLIN ORAL SUSP | DirectRx | ec7dd735-dc92-3d29-e053-2a95a90af549 | 2025-01-22 | Warnings, Adverse reactions | 72189-385 |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 5b2a2e62-6fd2-4ab1-b936-8702e68233fa | 2025-01-08 | Warnings, Adverse reactions | 065322 ANDA065322 50090-0406 |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 5f8b3c58-ed9f-84a2-e053-2a91aa0ac8cf | 2024-12-27 | Warnings, Adverse reactions | 065322 ANDA065322 68071-1760 |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 5c60cb1c-3baf-3af2-e053-2a91aa0ae208 | 2024-12-27 | Warnings, Adverse reactions | 065322 ANDA065322 68071-1761 |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 0b5acc3f-c474-4b16-9d66-8048abb3b22d | 2024-11-04 | Warnings, Adverse reactions | 065322 ANDA065322 50090-0411 |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals Inc. | 2177c68d-2884-ce70-e063-6294a90aa267 | 2024-09-06 | Warnings, Adverse reactions | 065322 ANDA065322 |
| Amoxicillin | AMOXICILLIN | Proficient Rx LP | 6a9cfa97-3715-4b75-a1e3-932a34a942d4 | 2024-03-01 | Warnings, Adverse reactions | 065322 ANDA065322 63187-295 |
| Amoxicillin | AMOXICILLIN | Hikma Pharmaceuticals USA Inc. | 077f4a65-3cfb-4cb1-99f2-e27ffc5939c0 | 2024-02-01 | Warnings, Adverse reactions | 065322 ANDA065322 0143-9888 0143-9889 |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | ca2886d0-7be7-4d41-bad5-df3ad44e0e7e | 2023-12-09 | Warnings, Adverse reactions | 065322 ANDA065322 50090-0407 |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 6c7bccff-00bf-46b0-a9ee-eb27d38d7377 | 2023-02-04 | Warnings, Adverse reactions | 065322 ANDA065322 50090-2251 |
| Amoxicillin | AMOXICILLIN | Proficient Rx LP | 9cac2bf2-fb48-4e83-b953-61c4d55f7e19 | 2022-11-01 | Warnings, Adverse reactions | 065322 ANDA065322 63187-029 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0143-9888 | Amoxicillin | Amoxicillin | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9888 | Amoxicillin | Amoxicillin | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9888 | Amoxicillin | Amoxicillin | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-9889 | Amoxicillin | Amoxicillin | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9889 | Amoxicillin | Amoxicillin | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9889 | Amoxicillin | Amoxicillin | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 33261-460 | Amoxicillin | Amoxicillin | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-602 | Amoxicillin | Amoxicillin | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-726 | Amoxicillin | Amoxicillin | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 50090-0404 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50090-0405 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50090-0405 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50090-0406 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50090-0407 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50090-0407 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50090-0411 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50090-2251 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50090-2251 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 52959-613 | Amoxicillin | Amoxicillin | H.J. Harkins Company, Inc. | ANDA | Current |
| 59115-044 | Amoxicillin | Amoxicillin | Hikma Pharmaceutical | ANDA | Current |
| 59115-046 | Amoxicillin | Amoxicillin | Hikma Pharmaceutical | ANDA | Current |
| 61919-015 | AMOXICILLIN | AMOXICILLIN | DIRECT RX | ANDA | Current |
| 61919-015 | AMOXICILLIN | AMOXICILLIN | DIRECT RX | ANDA | Current |
| 61919-716 | AMOXIL | AMOXICILLIN | Direct_Rx | ANDA | Current |
| 61919-716 | AMOXIL | AMOXICILLIN | Direct_Rx | ANDA | Current |
| 63187-029 | Amoxicillin | Amoxicillin | Proficient Rx LP | ANDA | Current |
| 63187-029 | Amoxicillin | Amoxicillin | Proficient Rx LP | ANDA | Current |
| 63187-029 | Amoxicillin | Amoxicillin | Proficient Rx LP | ANDA | Current |
| 63187-195 | Amoxicillin | Amoxicillin | Proficient Rx LP | ANDA | Current |
| 63187-195 | Amoxicillin | Amoxicillin | Proficient Rx LP | ANDA | Current |
| 63187-295 | Amoxicillin | Amoxicillin | Proficient Rx LP | ANDA | Current |
| 63187-295 | Amoxicillin | Amoxicillin | Proficient Rx LP | ANDA | Current |
| 66267-993 | Amoxicillin | Amoxicillin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 66267-993 | Amoxicillin | Amoxicillin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1760 | Amoxicillin | Amoxicillin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1760 | Amoxicillin | Amoxicillin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1760 | Amoxicillin | Amoxicillin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1761 | Amoxicillin | Amoxicillin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1761 | Amoxicillin | Amoxicillin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1761 | Amoxicillin | Amoxicillin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2364 | Amoxicillin | Amoxicillin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-9017 | Amoxicillin | Amoxicillin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9017 | Amoxicillin | Amoxicillin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9017 | Amoxicillin | Amoxicillin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9017 | Amoxicillin | Amoxicillin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9017 | Amoxicillin | Amoxicillin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9019 | Amoxicillin | Amoxicillin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9019 | Amoxicillin | Amoxicillin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9019 | Amoxicillin | Amoxicillin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9019 | Amoxicillin | Amoxicillin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9019 | Amoxicillin | Amoxicillin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 72189-385 | Amoxil | Amoxicillin Oral Susp | DirectRx | ANDA | Current |