Application 061931
- Type
- ANDA
- Sponsor
- TEVA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMOXICILLIN | AMOXICILLIN | FOR SUSPENSION;ORAL | 125MG/5ML | No | No |
| 002 | AMOXICILLIN | AMOXICILLIN | FOR SUSPENSION;ORAL | 250MG/5ML | No | Yes |
| 003 | AMOXICILLIN PEDIATRIC | AMOXICILLIN | FOR SUSPENSION;ORAL | 50MG/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A061931-001 | AMOXICILLIN | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | ||
| A061931-002 | AMOXICILLIN | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION / ORAL | AB | RS, Approved before 1982 | |
| A061931-003 | AMOXICILLIN PEDIATRIC | AMOXICILLIN | 50MG/ML | FOR SUSPENSION / ORAL | AB | 1982-12-01 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A061931-002 | AB |
| A061931-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A061931-001 | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A061931-002 | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION / ORAL | AB | RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A061931-003 | AMOXICILLIN PEDIATRIC | 50MG/ML | FOR SUSPENSION / ORAL | AB | 1982-12-01 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A061931-001 | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A061931-002 | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION / ORAL | AB | RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A061931-003 | AMOXICILLIN PEDIATRIC | 50MG/ML | FOR SUSPENSION / ORAL | AB | 1982-12-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A061931-001 | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A061931-002 | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION / ORAL | AB | RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A061931-003 | AMOXICILLIN PEDIATRIC | 50MG/ML | FOR SUSPENSION / ORAL | AB | 1982-12-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A061931-001 | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A061931-002 | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION / ORAL | AB | RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A061931-003 | AMOXICILLIN PEDIATRIC | 50MG/ML | FOR SUSPENSION / ORAL | AB | 1982-12-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A061931-001 | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A061931-002 | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION / ORAL | AB | RS, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A061931-003 | AMOXICILLIN PEDIATRIC | 50MG/ML | FOR SUSPENSION / ORAL | AB | 1982-12-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A061931-001 | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A061931-002 | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION / ORAL | AB | RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A061931-003 | AMOXICILLIN PEDIATRIC | 50MG/ML | FOR SUSPENSION / ORAL | AB | 1982-12-01 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A061931-001 | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A061931-002 | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION / ORAL | AB | RS, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A061931-003 | AMOXICILLIN PEDIATRIC | 50MG/ML | FOR SUSPENSION / ORAL | AB | 1982-12-01 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A061931-001 | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A061931-002 | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION / ORAL | AB | RS, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A061931-003 | AMOXICILLIN PEDIATRIC | 50MG/ML | FOR SUSPENSION / ORAL | AB | 1982-12-01 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A061931-001 | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A061931-002 | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION / ORAL | AB | RS, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A061931-003 | AMOXICILLIN PEDIATRIC | 50MG/ML | FOR SUSPENSION / ORAL | AB | 1982-12-01 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A061931-001 | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A061931-002 | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION / ORAL | AB | RS, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A061931-003 | AMOXICILLIN PEDIATRIC | 50MG/ML | FOR SUSPENSION / ORAL | AB | 1982-12-01 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A061931-001 | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A061931-002 | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION / ORAL | AB | RS, Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A061931-003 | AMOXICILLIN PEDIATRIC | 50MG/ML | FOR SUSPENSION / ORAL | AB | 1982-12-01 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A061931-001 | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A061931-002 | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION / ORAL | AB | RS, Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A061931-003 | AMOXICILLIN PEDIATRIC | 50MG/ML | FOR SUSPENSION / ORAL | AB | 1982-12-01 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A061931-001 | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A061931-002 | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION / ORAL | AB | RS, Approved before 1982 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A061931-003 | AMOXICILLIN PEDIATRIC | 50MG/ML | FOR SUSPENSION / ORAL | AB | 1982-12-01 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A061931-001 | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A061931-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A061931-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A061931-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A061931-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A061931-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A061931-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A061931-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A061931-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A061931-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A061931-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A061931-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A061931-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A061931-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A061931-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A061931-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A061931-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A061931-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A061931-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A061931-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A061931-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A061931-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A061931-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A061931-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A061931-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A061931-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A061931-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A061931-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A061931-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A061931-002 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A061931-003 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A061931-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A061931-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A061931-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A061931-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A061931-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A061931-003 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A061931-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A061931-003 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A061931-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A061931-003 | AB | 1 | bb7c543d1eb4… |
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 | Chartwell RX, LLC | b07b5ac4-253e-4c83-91c3-3fdc46e91a0f | 2026-07-24 | Warnings, Adverse reactions | 061931 ANDA061931 |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | cf707c13-3b40-079c-e053-2995a90a2176 | 2025-02-10 | Warnings, Adverse reactions | 061931 ANDA061931 68071-2558 |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 5780c9e4-5e22-270c-e053-2a91aa0a36ba | 2024-08-14 | Warnings, Adverse reactions | 061931 ANDA061931 66267-994 |
| Amoxicillin | AMOXICILLIN | Teva Pharmaceuticals USA, Inc. | 4c0f348a-a65d-409c-8668-207c82a5e3cb | 2024-05-22 | Warnings, Adverse reactions | 061931 ANDA061931 0093-4155 |
| Amoxicillin | AMOXICILLIN | A-S Medication Solutions | 63b395ca-f0ea-4429-b8aa-18f495596e4d | 2024-04-29 | Warnings, Adverse reactions | 50090-3005 |
| Amoxicillin | AMOXICILLIN | Asclemed USA, Inc. | bfd67724-fb22-4eac-8ebd-555614c16329 | 2023-06-17 | Warnings, Adverse reactions | 061931 ANDA061931 |
| Amoxicillin | AMOXICILLIN | Proficient Rx LP | de792ac6-4b3d-4d34-8e50-030b5bd830d7 | 2022-06-01 | Warnings, Adverse reactions | 061931 ANDA061931 63187-186 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0093-4150 | Amoxicillin | Amoxicillin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-4150 | Amoxicillin | Amoxicillin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-4150 | Amoxicillin | Amoxicillin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-4155 | Amoxicillin | Amoxicillin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-4155 | Amoxicillin | Amoxicillin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-4155 | Amoxicillin | Amoxicillin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-4155 | Amoxicillin | Amoxicillin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 21695-384 | Amoxicillin | Amoxicillin | Rebel Distributors Corp. | ANDA | Current |
| 21695-385 | Amoxicillin | Amoxicillin | Rebel Distributors Corp. | ANDA | Current |
| 50090-1807 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 50090-3005 | Amoxicillin | Amoxicillin | A-S Medication Solutions | ANDA | Current |
| 53002-2091 | Amoxicillin | Amoxicillin | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53217-312 | Amoxicillin | Amoxicillin | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 53217-314 | Amoxicillin | Amoxicillin | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 61919-018 | AMOXICILLIN | amoxicillin powder, for suspension | Direct RX | ANDA | Current |
| 63187-186 | Amoxicillin | Amoxicillin | Proficient Rx LP | ANDA | Current |
| 63187-186 | Amoxicillin | Amoxicillin | Proficient Rx LP | ANDA | Current |
| 63187-186 | Amoxicillin | Amoxicillin | Proficient Rx LP | ANDA | Current |
| 63187-200 | Amoxicillin | Amoxicillin | Proficient Rx LP | ANDA | Current |
| 63187-200 | Amoxicillin | Amoxicillin | Proficient Rx LP | ANDA | Current |
| 66116-223 | Amoxicillin | Amoxicillin | MedVantx, Inc. | ANDA | Current |
| 66267-994 | Amoxicillin | Amoxicillin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 66267-994 | Amoxicillin | Amoxicillin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 66267-994 | Amoxicillin | Amoxicillin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1526 | Amoxicillin | Amoxicillin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1526 | Amoxicillin | Amoxicillin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1526 | Amoxicillin | Amoxicillin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2558 | Amoxicillin | Amoxicillin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4196 | Amoxicillin | Amoxicillin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4696 | Amoxicillin | Amoxicillin | NuCare Pharmaceuticals,In | ANDA | Current |
| 68071-4696 | Amoxicillin | Amoxicillin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4696 | Amoxicillin | Amoxicillin | NuCare Pharmaceuticals,Inc. | ANDA | Current |