Application 065093
- Type
- ANDA
- Sponsor
- SANDOZ INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | TABLET;ORAL | 875MG;EQ 125MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A065093-001 | 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 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A065093-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET / ORAL | AB | 2002-11-21 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-09-29 23:25 UTC | 2022-09 | A065093-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A065093-001 | AB | 1 | cb3db0bc1861… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A065093-001 | AB | 1 | a50c72e98297… |
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.
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 |
|---|---|---|---|---|---|
| 10544-951 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | Blenheim Pharmacal, Inc. | ANDA | Current |
| 16714-478 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | Northstar RxLLC | ANDA | Current |
| 16714-478 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | Northstar RxLLC | ANDA | Current |
| 50090-4922 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | A-S Medication Solutions | ANDA | Current |
| 50436-1001 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | Unit Dose Services | ANDA | Current |
| 53002-7891 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-7891 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-7898 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-7898 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53808-0740 | Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55700-456 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 61919-637 | AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN AND CLAVULANATE POTASSIUM | DirectRX | ANDA | Current |
| 61919-637 | AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN AND CLAVULANATE POTASSIUM | DirectRX | ANDA | Current |
| 63187-423 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | Proficient Rx LP | ANDA | Current |
| 63187-423 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | Proficient Rx LP | ANDA | Current |
| 63187-423 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | Proficient Rx LP | ANDA | Current |
| 63187-423 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | Proficient Rx LP | ANDA | Current |
| 66685-1001 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | Sandoz Inc | ANDA | Current |
| 66685-1001 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | Sandoz Inc | ANDA | Current |
| 66685-1001 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | Sandoz Inc | ANDA | Current |
| 68071-2851 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4193 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4204 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4205 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-9319 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9319 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9319 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9319 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9319 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-1508 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1508 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2325 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2325 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2325 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2325 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2325 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | REMEDYREPACK INC. | ANDA | Current |
| 70934-086 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-086 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-086 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-086 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71205-719 | Amoxicillin and Clavulanate Potassium | amoxicillin and clavulanate potassium | Proficient Rx LP | ANDA | Current |
| 80425-0217 | Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 22311 | ORIG | 2005-07-22 |