Application 065271
- Type
- ANDA
- Sponsor
- AUROBINDO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMOXICILLIN | AMOXICILLIN | CAPSULE;ORAL | 250MG | No | No |
| 002 | AMOXICILLIN | AMOXICILLIN | CAPSULE;ORAL | 500MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A065271-001 | AMOXICILLIN | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | |
| A065271-002 | AMOXICILLIN | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A065271-001 | AB |
| A065271-002 | 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 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / ORAL | AB | 2005-11-09 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065271-001 | AMOXICILLIN | 250MG | CAPSULE / ORAL | AB | 2005-11-09 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065271-002 | AMOXICILLIN | 500MG | CAPSULE / 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 | A065271-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A065271-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A065271-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A065271-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A065271-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A065271-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065271-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065271-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A065271-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A065271-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065271-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065271-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065271-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065271-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065271-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065271-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065271-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065271-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065271-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065271-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065271-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065271-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A065271-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A065271-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065271-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065271-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065271-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065271-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065271-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065271-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A065271-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A065271-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065271-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065271-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A065271-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A065271-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A065271-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A065271-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A065271-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A065271-002 | 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 | Advanced Rx Pharmacy of Tennessee, LLC | f4c36acc-828d-323b-e053-2a95a90a4d1c | 2024-12-31 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | Asclemed USA, Inc. | a56d7a5e-2b2c-4121-9d9c-a3283b3cebf9 | 2024-11-05 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | e13cafe2-f226-4021-81d8-7bd1f98b5582 | 2024-11-04 | Warnings, Adverse reactions | 065271 ANDA065271 50090-1794 |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 05e88717-2ce3-4b1a-88af-c3f61a2d8cd5 | 2024-11-04 | Warnings, Adverse reactions | 065271 ANDA065271 50090-1797 |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 5edc5d32-43d5-4418-9832-40363a919edc | 2024-11-04 | Warnings, Adverse reactions | 065271 ANDA065271 50090-1826 50090-1795 |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 3b5a9e0f-a9d7-40e8-8c36-c91f6ec2e3c6 | 2024-11-04 | Warnings, Adverse reactions | 065271 ANDA065271 50090-1796 |
| Amoxicillin | AMOXICILLIN | Asclemed USA, Inc. | 9cd42f6f-cc7a-43f5-98dd-a5d6210933ae | 2024-08-14 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 8f8b1fe6-23cb-2105-e053-2a95a90aeede | 2024-07-10 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 7ee6b6b6-ae5b-2e39-e053-2991aa0a2377 | 2024-06-28 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 8995ac88-a094-2d16-e053-2a95a90a9a26 | 2024-06-14 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 8af9b9ee-8a64-53f5-e053-2a95a90a62a4 | 2024-06-14 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 7524da98-b0a5-3db8-e053-2a91aa0a6ff1 | 2024-06-10 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 322feb95-8bd4-440a-bda2-29ee19b11234 | 2024-04-15 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 4d0f063a-d896-4757-8f22-9614e2ad71d4 | 2024-04-11 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 73219f24-6eac-4472-b2a7-cad36936c185 | 2024-04-11 | Warnings, Adverse reactions | 065271 ANDA065271 50090-1813 |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 26202694-cf20-4b08-90cc-70a3d30cbb0f | 2024-04-11 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | NorthStar Rx LLC | 843f6053-63d9-47d2-81f1-b6aa78a7c20c | 2024-03-02 | Warnings, Adverse reactions | 065271 ANDA065271 16714-299 16714-298 |
| Amoxicillin | AMOXICILLIN | Rising Pharma Holdings, Inc. | bbe590a0-4196-4885-b679-cc1833af567f | 2024-02-27 | Warnings, Adverse reactions | 065271 ANDA065271 57237-031 57237-030 |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 116f655e-e32f-5030-e063-6394a90a64e5 | 2024-02-15 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | Aurobindo Pharma Limited | 7e3a4517-1934-4e03-b96b-4ad65ab076c5 | 2024-01-23 | Warnings, Adverse reactions | 065271 ANDA065271 |
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 |
|---|---|---|---|---|---|
| 12634-183 | Amoxicillin | Amoxicillin | Apotheca Inc. | ANDA | Current |
| 12634-185 | Amoxicillin | Amoxicillin | Apotheca Inc. | ANDA | Current |
| 16714-298 | Amoxicillin | Amoxicillin | NorthStar Rx LLC | ANDA | Current |
| 16714-298 | Amoxicillin | Amoxicillin | NorthStar Rx LLC | ANDA | Current |
| 16714-298 | Amoxicillin | Amoxicillin | NorthStar Rx LLC | ANDA | Current |
| 16714-299 | Amoxicillin | Amoxicillin | NorthStar Rx LLC | ANDA | Current |
| 16714-299 | Amoxicillin | Amoxicillin | NorthStar Rx LLC | ANDA | Current |
| 16714-299 | Amoxicillin | Amoxicillin | NorthStar Rx LLC | ANDA | Current |
| 21695-314 | Amoxicillin | Amoxicillin | Rebel Distributors Corp. | ANDA | Current |
| 21695-315 | Amoxicillin | Amoxicillin | Rebel Distributors Corp. | ANDA | Current |
| 33261-137 | Amoxicillin | Amoxicillin | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-144 | Amoxicillin | Amoxicillin | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 42708-076 | Amoxicillin | Amoxicillin | QPharma Inc | ANDA | Current |
| 42708-076 | Amoxicillin | Amoxicillin | QPharma Inc | ANDA | Current |
| 43063-563 | Amoxicillin | Amoxicillin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-563 | Amoxicillin | Amoxicillin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-563 | Amoxicillin | Amoxicillin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-563 | Amoxicillin | Amoxicillin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-574 | Amoxicillin | Amoxicillin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-574 | Amoxicillin | Amoxicillin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-574 | Amoxicillin | Amoxicillin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-574 | Amoxicillin | Amoxicillin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-574 | Amoxicillin | Amoxicillin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-574 | Amoxicillin | Amoxicillin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-574 | Amoxicillin | Amoxicillin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-820 | Amoxicillin | Amoxicillin | PD-Rx Pharmaceuticals, In | ANDA | Current |
| 43063-820 | Amoxicillin | Amoxicillin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-820 | Amoxicillin | Amoxicillin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-820 | Amoxicillin | Amoxicillin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-820 | Amoxicillin | Amoxicillin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-820 | Amoxicillin | Amoxicillin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-820 | Amoxicillin | Amoxicillin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-820 | Amoxicillin | Amoxicillin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-915 | Amoxicillin | Amoxicillin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-915 | Amoxicillin | Amoxicillin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-915 | Amoxicillin | Amoxicillin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-915 | Amoxicillin | Amoxicillin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-915 | Amoxicillin | Amoxicillin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-915 | Amoxicillin | Amoxicillin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 50090-0288 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50090-1511 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50090-1511 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50090-1512 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50090-1512 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50090-1512 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50090-1513 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50090-1513 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50090-1514 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50090-1794 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50090-1794 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50090-1795 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50090-1796 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50090-1797 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50090-1813 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50090-1826 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50090-1826 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50090-3187 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50436-0031 | Amoxicillin | Amoxicillin | Unit Dose Services | ANDA | Current |
| 50436-0031 | Amoxicillin | Amoxicillin | Unit Dose Services | ANDA | Current |
| 51655-156 | Amoxicillin | Amoxicillin | Northwind Pharmaceuticals, LLC | ANDA | Current |
| 52959-011 | Amoxicillin | Amoxicillin | H.J. Harkins Company, Inc. | ANDA | Current |
| 52959-020 | Amoxicillin | Amoxicillin | H.J. Harkins Company, Inc. | ANDA | Current |
| 53002-2080 | Amoxicillin | Amoxicillin | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-2080 | Amoxicillin | Amoxicillin | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-2160 | Amoxicillin | Amoxicillin | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-2160 | Amoxicillin | Amoxicillin | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 55700-007 | Amoxicillin | Amoxicillin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-007 | Amoxicillin | Amoxicillin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-007 | Amoxicillin | Amoxicillin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-007 | Amoxicillin | Amoxicillin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-007 | Amoxicillin | Amoxicillin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-308 | Amoxicillin | Amoxicillin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-406 | Amoxicillin | Amoxicillin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-406 | Amoxicillin | Amoxicillin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-406 | Amoxicillin | Amoxicillin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-560 | Amoxicillin | Amoxicillin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 57237-030 | Amoxicillin | Amoxicillin | Rising Health, LLC | ANDA | Current |
| 57237-030 | Amoxicillin | Amoxicillin | Rising Health, LLC | ANDA | Current |
| 57237-030 | Amoxicillin | Amoxicillin | Rising Health, LLC | ANDA | Current |
| 57237-031 | Amoxicillin | Amoxicillin | Rising Health, LLC | ANDA | Current |