Application 090624
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA
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 |
|---|---|---|---|---|---|---|---|
| A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | |
| A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090624-001 | AB |
| A090624-002 | 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 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | 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 | A090624-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A090624-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A090624-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090624-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A090624-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090624-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090624-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090624-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090624-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090624-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090624-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090624-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090624-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090624-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090624-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090624-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090624-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090624-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090624-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090624-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090624-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090624-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090624-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090624-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090624-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090624-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090624-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090624-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090624-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090624-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A090624-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A090624-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090624-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090624-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A090624-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A090624-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A090624-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A090624-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A090624-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A090624-002 | 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 | Pharmasource Meds, LLC | f564a029-4b20-301a-e053-2995a90adcc0 | 2024-05-28 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | NCS HealthCare of KY, LLC dba Vangard Labs | c2307cc2-43ee-4319-ad58-d1d28a95e5aa | 2024-02-05 | Warnings, Adverse reactions | 090624 ANDA090624 0615-8121 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Proficient Rx LP | befcc5b0-04bb-4211-b3dd-88f400c7fa78 | 2023-08-01 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | A-S Medication Solutions | d8239804-d234-491b-965d-89a7796a5e4d | 2023-02-04 | Warnings, Adverse reactions | 090624 ANDA090624 50090-2479 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | a12bf393-d8ef-48df-e053-2a95a90a1af1 | 2023-01-01 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Proficient Rx LP | 29e83667-8d4a-49b7-9182-653cbfb2dee7 | 2022-05-02 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Asclemed USA, Inc. | e6c0f80a-ba22-4690-aaf8-48a4602b6831 | 2020-09-04 | Warnings, Adverse reactions | 090624 ANDA090624 |
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 |
|---|---|---|---|---|---|
| 0179-0249 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | KAISER FOUNDATION HOSPITALS | ANDA | Current |
| 0615-8121 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 10544-053 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Blenheim Pharmacal, Inc. | ANDA | Current |
| 42292-028 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Mylan Institutional Inc. | ANDA | Current |
| 42292-028 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Mylan Institutional Inc. | ANDA | Current |
| 42708-053 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | QPharma Inc | ANDA | Current |
| 42708-053 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | QPharma Inc | ANDA | Current |
| 42708-053 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | QPharma, Inc. | ANDA | Current |
| 50090-2198 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | A-S Medication Solutions | ANDA | Current |
| 50090-2198 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | A-S Medication Solutions | ANDA | Current |
| 50090-2198 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | A-S Medication Solutions | ANDA | Current |
| 50090-2198 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | A-S Medication Solutions | ANDA | Current |
| 50090-2199 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | A-S Medication Solutions | ANDA | Current |
| 50090-2199 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | A-S Medication Solutions | ANDA | Current |
| 50090-2199 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | A-S Medication Solutions | ANDA | Current |
| 50090-2199 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | A-S Medication Solutions | ANDA | Current |
| 50090-2200 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | A-S Medication Solutions | ANDA | Current |
| 50090-2200 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | A-S Medication Solutions | ANDA | Current |
| 50090-2200 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | A-S Medication Solutions | ANDA | Current |
| 50090-2200 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | A-S Medication Solutions | ANDA | Current |
| 50090-2201 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | A-S Medication Solutions | ANDA | Current |
| 50090-2201 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | A-S Medication Solutions | ANDA | Current |
| 50090-2201 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | A-S Medication Solutions | ANDA | Current |
| 50090-2201 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | A-S Medication Solutions | ANDA | Current |
| 50090-2201 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | A-S Medication Solutions | ANDA | Current |
| 50090-2479 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | A-S Medication Solutions | ANDA | Current |
| 50090-2479 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | A-S Medication Solutions | ANDA | Current |
| 50090-2479 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | A-S Medication Solutions | ANDA | Current |
| 50090-2479 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | A-S Medication Solutions | ANDA | Current |
| 50090-3973 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | A-S Medication Solutions | ANDA | Current |
| 50090-4430 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | A-S Medication Solutions | ANDA | Current |
| 50090-5679 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | A-S Medication Solutions | ANDA | Current |
| 50268-728 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | AvPAK | ANDA | Current |
| 50268-728 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | AvPAK | ANDA | Current |
| 50268-728 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | AvPAK | ANDA | Current |
| 50268-729 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | AvPAK | ANDA | Current |
| 50436-4694 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Unit Dose Services | ANDA | Current |
| 52343-009 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | LUCID PHARMA LLC | ANDA | Current |
| 52343-010 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | LUCID PHARMA LLC | ANDA | Current |
| 53002-2100 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-2100 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-2101 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-2101 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 55700-611 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-611 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-611 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Quality Care Products LLC | ANDA | Current |
| 55700-611 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-611 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Quality Care Products LLC | ANDA | Current |
| 55700-611 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 57237-232 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Rising Health, LLC | ANDA | Current |
| 57237-232 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Rising Health, LLC | ANDA | Current |
| 57237-232 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Rising Health, LLC | ANDA | Current |
| 57237-232 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Rising Health, LLC | ANDA | Current |
| 57237-232 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Rising Health, LLC | ANDA | Current |
| 57237-233 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Rising Health, LLC | ANDA | Current |
| 57237-233 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Rising Health, LLC | ANDA | Current |
| 57237-233 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Rising Health, LLC | ANDA | Current |
| 57237-233 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Rising Health, LLC | ANDA | Current |
| 57237-233 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Rising Health, LLC | ANDA | Current |
| 58118-0420 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Clinical Solutions Wholesale | ANDA | Current |
| 58118-0420 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Clinical Solutions Wholesale | ANDA | Current |
| 58118-0420 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Clinical Solutions Wholesale | ANDA | Current |
| 60687-603 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | American Health Packaging | ANDA | Current |
| 60687-603 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | American Health Packaging | ANDA | Current |
| 60687-603 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | American Health Packaging | ANDA | Current |
| 60687-603 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | American Health Packaging | ANDA | Current |
| 60687-614 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | American Health Packaging | ANDA | Current |
| 60687-614 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | American Health Packaging | ANDA | Current |
| 60687-614 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | American Health Packaging | ANDA | Current |
| 60687-614 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | American Health Packaging | ANDA | Current |
| 60760-069 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-069 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-069 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-069 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-069 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-541 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | ST. MARY'S MEDICAL PARK PHARMACY | ANDA | Current |
| 60760-541 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | ST. MARY'S MEDICAL PARK PHARMACY | ANDA | Current |
| 61919-144 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE AND TRIMETHOPRIM | DIRECT RX | ANDA | Current |
| 61919-144 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Direct_Rx | ANDA | Current |
| 61919-144 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Direct_Rx | ANDA | Current |