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 | Preferred Pharmaceuticals Inc. | d60c218c-6529-4944-af0b-a9dc720f32e9 | 2026-09-02 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | REMEDYREPACK INC. | ce44959b-4bfe-4ba9-9fc2-7f9d4663d542 | 2026-08-10 | Warnings, Adverse reactions | 090624 ANDA090624 70518-3454 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | REMEDYREPACK INC. | ec2e335c-3357-40d8-9615-a09fc40ce5f4 | 2026-08-07 | Warnings, Adverse reactions | 090624 ANDA090624 70518-3432 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | REMEDYREPACK INC. | c45ac3a4-d397-486e-abd1-349916543068 | 2026-07-27 | Warnings, Adverse reactions | 090624 ANDA090624 70518-2604 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Cardinal Health 107, LLC | 08500fcb-dbec-4ac2-91c3-189d27907ec0 | 2026-07-17 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Unit Dose Solutions, Inc. | 562e2547-db2d-e2d2-e063-6294a90a1f5d | 2026-07-09 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | St. Mary's Medical Park Pharmacy | e3a49508-0ebe-1334-e053-2a95a90ae173 | 2026-06-11 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Coupler LLC | 518cc045-a12b-f08f-e063-6394a90acb0c | 2026-05-11 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | AvPAK | 29df8839-3dfa-0b2b-c5a3-906db6997b3b | 2026-03-24 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | A-S Medication Solutions | 75b9d194-b960-4943-bedc-96e3d65c4da9 | 2026-03-03 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | NuCare Pharmaceuticals,Inc. | 7f82e5e0-b627-a3f3-e053-2991aa0abaa5 | 2026-02-09 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Sportpharm LLC | 52304e5e-d097-48f2-8b64-210908e4eb54 | 2026-02-03 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | REMEDYREPACK INC. | 99e1ace6-7665-4f87-82fd-5e7c4989e098 | 2026-01-13 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfameth/Trimeth-DS | SULFAMETH/TRIMETH-DS | Direct_Rx | 90026ce8-3305-6272-e053-2995a90a57e0 | 2026-01-08 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | NuCare Pharmaceuticals,Inc. | 8c3e4738-0e0a-a854-e053-2995a90a7d71 | 2026-01-05 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Northwind Health Company, LLC | f7f97520-d063-ec87-e053-6294a90aae0c | 2026-01-01 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Northwind Health Company, LLC | 471c5995-a4df-fbe3-e063-6394a90aa50e | 2025-12-29 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | QPharma, Inc. | 41529314-b203-47f4-88dd-5aa57c74985f | 2025-12-02 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | VERITYRX, LLC | 427b8040-99a4-8e81-e063-6394a90a76c5 | 2025-10-31 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | NuCare Pharmaceuticals,Inc. | 1274cefb-0799-e2e4-e063-6394a90aad02 | 2025-10-07 | 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 |
|---|---|---|---|---|---|
| 70518-1400 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-1400 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-1400 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-1400 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-2604 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-2604 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-2604 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-2604 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-2604 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-2604 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-2604 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-2604 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-2604 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-2604 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-2604 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-2604 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-2604 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-2604 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-3432 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-3432 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-3454 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70934-049 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-049 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-544 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-544 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71335-0762 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Bryant Ranch Prepack | ANDA | Current |
| 71335-0762 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Bryant Ranch Prepack | ANDA | Current |
| 71335-0762 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Bryant Ranch Prepack | ANDA | Current |
| 71335-1309 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Bryant Ranch Prepack | ANDA | Current |
| 71335-1309 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Bryant Ranch Prepack | ANDA | Current |
| 72789-018 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-018 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-018 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-018 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-018 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-018 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-018 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-018 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-064 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-064 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-064 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-064 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 76413-125 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Central Texas Community Health Centers | ANDA | Current |
| 76420-064 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Asclemed USA, Inc. | ANDA | Current |
| 76420-064 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Asclemed USA, Inc. | ANDA | Current |
| 80425-0002 | Bactrim DS | SULFAMETHOXAZOLE TMP DS | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0002 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0002 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0003 | Bactrim DS | SULFAMETHOXAZOLE TMP DS | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0003 | Bactrim DS | SULFAMETHOXAZOLE TMP DS | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0003 | Bactrim DS | SULFAMETHOXAZOLE TMP DS | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0003 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0003 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |