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 | QPharma Inc | 2772a745-1276-405b-b229-95edf5534b2a | 2025-12-05 | Warnings, Adverse reactions | 065271 ANDA065271 42708-076 |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 071086f5-e4ed-b1d9-e063-6294a90ad304 | 2025-11-13 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | Bryant Ranch Prepack | bbaeb509-ad04-4668-a1db-4358038893f2 | 2025-10-23 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | PD-Rx Pharmaceuticals, Inc. | d0938df9-9065-47eb-9eae-0722ed1411a1 | 2025-10-17 | Warnings, Adverse reactions | 065271 ANDA065271 43063-820 |
| Amoxicillin | AMOXICILLIN | PD-Rx Pharmaceuticals, Inc. | 987786a1-d748-4b42-abb5-62a2f38ef195 | 2025-10-17 | Warnings, Adverse reactions | 065271 ANDA065271 43063-915 |
| Amoxicillin | AMOXICILLIN | Bryant Ranch Prepack | 1c755ad7-f0a8-4a63-a686-413bae57f8d0 | 2025-06-20 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | Bryant Ranch Prepack | 5d0132d0-1d5a-46d0-bc62-76d62a7bd19d | 2025-06-03 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | Bryant Ranch Prepack | c0343d5e-96b2-46fa-bf54-e2ffa0c90b41 | 2025-06-03 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | Bryant Ranch Prepack | 95eaa9ac-c64a-4f1d-b5a3-66489d5b1edb | 2025-06-03 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceutials,Inc. | 1f818d89-be59-b43d-e063-6394a90a12c3 | 2025-05-28 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | PD-Rx Pharmaceuticals, Inc. | d37f2e3c-01f0-4a81-a46f-1615b82e2499 | 2025-04-17 | Warnings, Adverse reactions | 065271 ANDA065271 43063-574 |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | e58a65d7-d813-446d-b70b-7465809a5d2c | 2025-04-09 | Warnings, Adverse reactions | 065271 ANDA065271 50090-1513 |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 641ec2a8-368a-4c5c-8c11-37366a06ce93 | 2025-04-08 | Warnings, Adverse reactions | 065271 ANDA065271 50090-1514 |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 9d56f34f-c025-4e97-8f5e-4d93f1ab0055 | 2025-04-08 | Warnings, Adverse reactions | 065271 ANDA065271 50090-1512 |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 4b15c5b4-460c-449f-9e48-99870b382826 | 2025-04-02 | Warnings, Adverse reactions | 065271 ANDA065271 50090-1511 |
| Amoxicillin | AMOXICILLIN | American Health Packaging | ecb439f7-434a-4e4c-b899-943d83346f09 | 2025-03-03 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals, Inc. | 4f1c940c-9f17-4289-e054-00144ff88e88 | 2025-02-04 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | Redpharm Drug | fc61c9f5-b0f8-3ff8-e053-6394a90adeb7 | 2025-01-23 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 6d7143e3-6a82-3613-e053-2a91aa0a8f65 | 2025-01-08 | Warnings, Adverse reactions | 065271 ANDA065271 |
| Amoxicillin | AMOXICILLIN | Northwind Pharmaceuticals, LLC | 26114563-c719-46da-b976-3e4271533f28 | 2025-01-02 | Warnings, Adverse reactions | 065271 ANDA065271 51655-156 |
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 |