Application 201090
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | FOR SUSPENSION;ORAL | 200MG/5ML;EQ 28.5MG BASE/5ML | No | No |
| 002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | FOR SUSPENSION;ORAL | 400MG/5ML;EQ 57MG BASE/5ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A201090-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | |
| A201090-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A201090-001 | AB |
| A201090-002 | 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 | A201090-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A201090-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A201090-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A201090-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201090-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201090-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201090-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201090-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201090-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201090-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201090-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201090-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201090-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201090-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201090-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201090-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201090-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201090-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201090-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201090-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201090-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201090-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A201090-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A201090-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201090-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201090-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201090-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201090-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A201090-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A201090-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A201090-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A201090-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A201090-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A201090-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A201090-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A201090-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A201090-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A201090-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A201090-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A201090-002 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2011-12-20 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-03-09 01:35 UTC | 2022-03 | A201090-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A201090-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A201090-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A201090-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A201090-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A201090-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A201090-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A201090-002 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A201090-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A201090-002 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A201090-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A201090-002 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A201090-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A201090-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A201090-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A201090-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A201090-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A201090-002 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A201090-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A201090-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A201090-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A201090-002 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A201090-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A201090-002 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A201090-001 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A201090-002 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A201090-001 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A201090-002 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A201090-001 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A201090-002 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A201090-001 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A201090-002 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A201090-001 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A201090-002 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A201090-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A201090-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A201090-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A201090-002 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A201090-001 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A201090-002 | AB | 1 | f41ea6bd6efb… |
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 and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | A-S Medication Solutions | 4937611d-bd61-4538-ad1e-bd67e9527955 | 2026-08-25 | Warnings, Adverse reactions | 201090 ANDA201090 50090-3309 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | HAWAII REPACK, INC. | 7fb0f56e-c098-49e4-b075-2eb8936582aa | 2026-07-13 | Warnings, Adverse reactions | 201090 ANDA201090 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | A-S Medication Solutions | ce488c24-2ec5-4d1b-b446-90f2497aa15d | 2026-07-06 | Warnings, Adverse reactions | 201090 ANDA201090 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | NuCare Pharmaceuticals,Inc. | ca664448-12fb-0c6f-e053-2995a90a262c | 2026-06-12 | Warnings, Adverse reactions | 201090 ANDA201090 68071-2518 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | Preferred Pharmaceuticals Inc. | 618953a3-0256-42ce-9155-d35325f017aa | 2026-03-02 | Warnings, Adverse reactions | 201090 ANDA201090 68788-8318 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | Preferred Pharmaceuticals Inc. | 30446852-9a54-4d16-ba12-56ffd0149985 | 2026-02-27 | Warnings, Adverse reactions | 201090 ANDA201090 68788-8306 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | A-S Medication Solutions | 77126eee-9534-4e80-9d11-ec78ec66c826 | 2026-02-19 | Warnings, Adverse reactions | 201090 ANDA201090 50090-5932 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | NuCare Pharmaceuticals, Inc. | 30144e2e-d336-8fa3-e063-6394a90a6068 | 2025-03-11 | Warnings, Adverse reactions | 201090 ANDA201090 |
| Amoxicillin/Clav Pot Oral Susp | AMOXICILLIN/CLAV POT ORAL SUSP | Direct_Rx | e5bd9918-b073-c50b-e053-2a95a90aaeb7 | 2025-01-22 | Warnings, Adverse reactions | 201090 ANDA201090 72189-367 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | NuCare Pharmaceuticals,Inc. | abbebdc1-4410-76af-e053-2a95a90acb9c | 2025-01-02 | Warnings, Adverse reactions | 201090 ANDA201090 68071-2227 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | Asclemed USA, Inc. | fc5dc69a-3c23-49fc-b80f-1412aebc9b76 | 2024-10-24 | Warnings, Adverse reactions | 201090 ANDA201090 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | Proficient Rx LP | aad174d9-2c46-49aa-9a62-61063f405c53 | 2024-09-01 | Warnings, Adverse reactions | 201090 ANDA201090 71205-462 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | NorthStar Rx LLC | f0a6d21d-203f-4fde-b010-a2730b86b491 | 2024-07-09 | Warnings, Adverse reactions | 201090 ANDA201090 16714-292 16714-293 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | A-S Medication Solutions | 2718248d-d948-466e-959b-1a972519f108 | 2024-05-14 | Warnings, Adverse reactions | 201090 ANDA201090 50090-5873 |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | A-S Medication Solutions | 61f9224b-a91b-4154-a7f3-22c14601230f | 2023-10-31 | Warnings, Adverse reactions | 201090 ANDA201090 50090-6222 |
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 |
|---|---|---|---|---|---|
| 16714-292 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | NorthStar Rx LLC | ANDA | Current |
| 16714-292 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | NorthStar Rx LLC | ANDA | Current |
| 16714-292 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | NorthStar Rx LLC | ANDA | Current |
| 16714-293 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | NorthStar Rx LLC | ANDA | Current |
| 16714-293 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | NorthStar Rx LLC | ANDA | Current |
| 16714-293 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | NorthStar Rx LLC | ANDA | Current |
| 33261-464 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-988 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-989 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 50090-3309 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | A-S Medication Solutions | ANDA | Current |
| 50090-3309 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | A-S Medication Solutions | ANDA | Current |
| 50090-5873 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | A-S Medication Solutions | ANDA | Current |
| 50090-5932 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | A-S Medication Solutions | ANDA | Current |
| 50090-6222 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | A-S Medication Solutions | ANDA | Current |
| 53002-0051 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 65862-533 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-533 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-533 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-533 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-533 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-534 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-534 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-534 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-534 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-534 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | Aurobindo Pharma Limited | ANDA | Current |
| 68071-2227 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2227 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2518 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2641 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-8306 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8318 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-9433 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 71205-462 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | Proficient Rx LP | ANDA | Current |
| 72189-367 | Amoxicillin/Clav Pot Oral Susp | Amoxicillin/Clav Pot Oral Susp | Direct_Rx | ANDA | Current |