Application 076899
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS NY
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | TABLET;ORAL | 400MG;80MG | No | No |
| 002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | TABLET;ORAL | 800MG;160MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | |
| A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076899-001 | AB |
| A076899-002 | 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 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | 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 | A076899-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A076899-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A076899-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076899-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A076899-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076899-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076899-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076899-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076899-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076899-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076899-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076899-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076899-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076899-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076899-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076899-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076899-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076899-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076899-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076899-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076899-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076899-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076899-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076899-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076899-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076899-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076899-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076899-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076899-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076899-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A076899-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A076899-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076899-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076899-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A076899-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A076899-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A076899-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A076899-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A076899-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076899-002 | 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 |
|---|---|---|---|---|---|---|
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Cardinal Health 107, LLC | 5dc03027-cdaf-461f-87fd-630d382fc723 | 2026-08-07 | Warnings, Adverse reactions | 076899 ANDA076899 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Amneal Pharmaceuticals LLC | f0e73842-6002-43c2-97fc-0cadc1bf6346 | 2026-04-02 | Warnings, Adverse reactions | 076899 ANDA076899 65162-271 65162-272 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | AvKARE | 9f130443-c8e7-9122-8f27-f72f07f3f29e | 2026-02-10 | Warnings, Adverse reactions | 076899 ANDA076899 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Northwind Health Company, LLC | f2b8e9d9-1274-22ca-e053-2a95a90a6f1a | 2026-01-01 | Warnings, Adverse reactions | 076899 ANDA076899 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Major Pharmaceuticals | abe0d2d5-4879-4b4e-9b57-47ea83a17ba0 | 2025-11-18 | Warnings, Adverse reactions | 076899 ANDA076899 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | A-S Medication Solutions | 0aaf1dbe-b69d-43bd-a4ab-69cb27ab417d | 2025-05-15 | Warnings, Adverse reactions | 076899 ANDA076899 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Amneal Pharmaceuticals of New York LLC | 3233c54d-484d-4550-b172-db8af47d1b7f | 2025-02-26 | Warnings, Adverse reactions | 076899 ANDA076899 |
| Sulfamethoxazole and Trimethoprim DS | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Advanced Rx Pharmacy of Tennessee, LLC | b001e648-2710-3ada-e053-2995a90a52f1 | 2024-12-31 | Warnings, Adverse reactions | 076899 ANDA076899 80425-0001 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Bryant Ranch Prepack | a174991a-53e7-c791-3cee-b706a48e0ec5 | 2024-10-09 | Warnings, Adverse reactions | 076899 ANDA076899 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | A-S Medication Solutions | f39a4c93-0a0e-4801-aecc-c55a2fa5e68b | 2024-01-08 | Warnings, Adverse reactions | 076899 ANDA076899 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | A-S Medication Solutions | ffc5d594-429c-4303-b3b6-f5a83e915b55 | 2024-01-08 | Warnings, Adverse reactions | 076899 ANDA076899 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | A-S Medication Solutions | 07a49665-fe2a-4a92-a57e-49db224b012e | 2024-01-08 | Warnings, Adverse reactions | 076899 ANDA076899 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | A-S Medication Solutions | 8661e318-ddf3-4a60-8781-6fa42307c60a | 2024-01-08 | Warnings, Adverse reactions | 076899 ANDA076899 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | A-S Medication Solutions | b85a58a7-74d6-4629-8027-0cdcbb5c815a | 2023-12-17 | Warnings, Adverse reactions | 076899 ANDA076899 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | A-S Medication Solutions | 07da67b1-b50c-4471-8cde-8a119eb8c935 | 2023-12-15 | Warnings, Adverse reactions | 076899 ANDA076899 |
| Sulfamethox-TMP DS | SULFAMETHOXAZOLE, TRIMETHOPRIM | PharmPak, Inc. | ede74118-32c5-4f52-9823-509538e674c8 | 2022-10-09 | Warnings, Adverse reactions | 076899 ANDA076899 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Proficient Rx LP | 0df74ba1-1aa6-467c-92e7-6b017c7c6bce | 2019-11-01 | Warnings, Adverse reactions | 076899 ANDA076899 |
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 |
|---|---|---|---|---|---|
| 63629-7941 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Bryant Ranch Prepack | ANDA | Current |
| 63629-7941 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Bryant Ranch Prepack | ANDA | Current |
| 63629-7956 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Bryant Ranch Prepack | ANDA | Current |
| 63629-7956 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Bryant Ranch Prepack | ANDA | Current |
| 63629-7956 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Bryant Ranch Prepack | ANDA | Current |
| 64205-272 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | ReadyMeds | ANDA | Current |
| 65162-271 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-271 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-271 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-271 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-271 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-272 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-272 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-272 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-272 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-272 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Amneal Pharmaceuticals LLC | ANDA | Current |
| 66116-369 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | MedVantx, Inc. | ANDA | Current |
| 67046-716 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Contract Pharmacy Services-PA | ANDA | Current |
| 67296-0227 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | RedPharm Drug, Inc. | ANDA | Current |
| 67296-0227 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | RedPharm Drug, Inc. | ANDA | Current |
| 67296-0227 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | RedPharm Drug, Inc. | ANDA | Current |
| 67296-0474 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | RedPharm Drug, Inc. | ANDA | Current |
| 67296-0474 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | RedPharm Drug, Inc. | ANDA | Current |
| 67296-0474 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | RedPharm Drug, Inc. | ANDA | Current |
| 68084-230 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | American Health Packaging | ANDA | Current |
| 68084-230 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | American Health Packaging | ANDA | Current |
| 68084-230 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | American Health Packaging | ANDA | Current |
| 68084-747 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | American Health Packaging | ANDA | Current |
| 68084-747 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | American Health Packaging | ANDA | Current |
| 68084-747 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | American Health Packaging | ANDA | Current |
| 68387-385 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Keltman Pharmaceuticals Inc. | ANDA | Current |
| 68788-8964 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8964 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8964 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Preferred Pharmaceuticals | ANDA | Current |
| 70518-0066 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-0066 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-0066 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-1517 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-1517 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-1517 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-2236 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-2838 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-2838 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-2838 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-3028 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 80425-0001 | Bactrim DS | Sulfamethoxazole TMP DS | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0001 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0001 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |