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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | c2088c7a36db… | |
| 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… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A090624-001 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A090624-002 | AB | 1 | c2088c7a36db… |
| 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… |
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 | American Health Packaging | 7f25bff3-0e86-4bec-b293-54b68347867f | 2025-07-23 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | PD-Rx Pharmaceuticals, Inc. | c4da9c4f-0704-4ed5-9d19-5c949f37f726 | 2025-04-30 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Cronus Pharma LLC | 1b5de94f-973a-4b5a-91d7-45e05be78650 | 2025-04-02 | Warnings, Adverse reactions | 090624 ANDA090624 69043-011 69043-010 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Rising Pharma Holdings, Inc. | e1a3748d-ca73-4e56-95ad-d25189cc346e | 2025-04-02 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | A-S Medication Solutions | 62616708-a538-459f-9b7f-ed90c6aa5fc6 | 2025-04-01 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | A-S Medication Solutions | 14767ff8-7803-4922-ac03-ff80c061e5ba | 2025-03-31 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | A-S Medication Solutions | fd90d8bd-1b84-4347-a98a-f8f94746f3e4 | 2025-03-31 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | A-S Medication Solutions | 4e12b7e1-fa2f-4cd1-ada6-19a7d5652348 | 2025-03-31 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | PD-Rx Pharmaceuticals, Inc. | 3ef62512-0dc3-4821-9b60-6b375841c4c0 | 2025-03-26 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Aurobindo Pharma Limited | 284b5dac-2b8d-46bf-95fe-80ce03fa178a | 2025-03-12 | Warnings, Adverse reactions | 090624 ANDA090624 65862-419 65862-420 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | A-S Medication Solutions | 8c74ea5c-d05e-4fc1-b980-aacaab56d472 | 2025-02-26 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | A-S Medication Solutions | 20054147-811c-471a-8ec4-1b2903fe906e | 2025-02-26 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | A-S Medication Solutions | a12fb7b0-9ff5-48f1-8fd9-4fbdfdbe09bc | 2025-02-26 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim DS | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Advanced Rx Pharmacy of Tennessee, LLC | afe8cb1c-7cfd-3378-e053-2a95a90a4db6 | 2024-12-31 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim DS | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Advanced Rx Pharmacy of Tennessee, LLC | b000150f-3be6-2e6c-e053-2995a90a67d5 | 2024-12-31 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Quality Care Products LLC | 079c828c-148f-45b9-966e-d8906043b2a2 | 2024-12-17 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | A-S Medication Solutions | 7d7ca48b-8655-4cfb-8db0-28eddf1feb9b | 2024-10-25 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Bryant Ranch Prepack | 27bebe39-c069-4a9d-99d1-c7cf44ac2f41 | 2024-10-07 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | NuCare Pharmaceuticals, Inc. | 3ed6bf70-2841-04f8-e054-00144ff8d46c | 2024-08-14 | Warnings, Adverse reactions | 090624 ANDA090624 66267-196 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | NuCare Pharmaceuticals, Inc. | 46dc8f62-e700-50e3-e054-00144ff8d46c | 2024-08-14 | Warnings, Adverse reactions | 090624 ANDA090624 66267-816 |
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 |
|---|---|---|---|---|---|
| 61919-144 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Direct_Rx | ANDA | Current |
| 61919-645 | SULFAMETH/TRIMETH-DS | SULFAMETH/TRIMETH-DS | DIRECT RX | ANDA | Current |
| 61919-645 | SULFAMETH/TRIMETH-DS | SULFAMETH/TRIMETH-DS | DirectRX | ANDA | Current |
| 61919-645 | Sulfameth/Trimeth-DS | Sulfameth/Trimeth-DS | Direct_Rx | ANDA | Current |
| 61919-645 | Sulfameth/Trimeth-DS | Sulfameth/Trimeth-DS | Direct_Rx | ANDA | Current |
| 61919-645 | Sulfameth/Trimeth-DS | Sulfameth/Trimeth-DS | Direct_Rx | ANDA | Current |
| 61919-645 | Sulfameth/Trimeth-DS | Sulfameth/Trimeth-DS | Direct_Rx | ANDA | Current |
| 61919-645 | Sulfameth/Trimeth-DS | Sulfameth/Trimeth-DS | Direct_Rx | ANDA | Current |
| 61919-645 | Sulfameth/Trimeth-DS | Sulfameth/Trimeth-DS | Direct_Rx | ANDA | Current |
| 61919-645 | Sulfameth/Trimeth-DS | Sulfameth/Trimeth-DS | Direct_Rx | ANDA | Current |
| 63187-695 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Proficient Rx LP | ANDA | Current |
| 63187-695 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Proficient Rx LP | ANDA | Current |
| 63187-695 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Proficient Rx LP | ANDA | Current |
| 63187-695 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Proficient Rx LP | ANDA | Current |
| 65862-419 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Aurobindo Pharma Limited | ANDA | Current |
| 65862-419 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Aurobindo Pharma Limited | ANDA | Current |
| 65862-419 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Aurobindo Pharma Limited | ANDA | Current |
| 65862-419 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Aurobindo Pharma Limited | ANDA | Current |
| 65862-419 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Aurobindo Pharma Limited | ANDA | Current |
| 65862-419 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Aurobindo Pharma Limited | ANDA | Current |
| 65862-419 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Aurobindo Pharma Limited | ANDA | Current |
| 65862-420 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Aurobindo Pharma Limited | ANDA | Current |
| 65862-420 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Aurobindo Pharma Limited | ANDA | Current |
| 65862-420 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Aurobindo Pharma Limited | ANDA | Current |
| 65862-420 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Aurobindo Pharma Limited | ANDA | Current |
| 65862-420 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Aurobindo Pharma Limited | ANDA | Current |
| 65862-420 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Aurobindo Pharma Limited | ANDA | Current |
| 65862-420 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Aurobindo Pharma Limited | ANDA | Current |
| 66267-196 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-196 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-816 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-816 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-816 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 67296-1327 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1327 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1552 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1552 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1612 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1612 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1612 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | RedPharm Drug, Inc. | ANDA | Current |
| 68071-4431 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4431 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4431 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4489 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4489 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4496 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4496 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4710 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4710 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4710 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4913 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4913 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4948 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4948 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4948 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7122 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7122 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7122 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7122 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7622 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7622 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7622 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 69043-010 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Cronus Pharma LLC | ANDA | Current |
| 69043-010 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Cronus Pharma LLC | ANDA | Current |
| 69043-010 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Cronus Pharma LLC | ANDA | Current |
| 69043-010 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Cronus Pharma LLC | ANDA | Current |
| 69043-010 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Cronus Pharma LLC | ANDA | Current |
| 69043-011 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Cronus Pharma LLC | ANDA | Current |
| 69043-011 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Cronus Pharma LLC | ANDA | Current |
| 69043-011 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Cronus Pharma LLC | ANDA | Current |
| 69043-011 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Cronus Pharma LLC | ANDA | Current |
| 69043-011 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | Cronus Pharma LLC | ANDA | Current |
| 70518-0863 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-0863 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-0863 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-0863 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-0863 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-0863 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-0863 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-1400 | Sulfamethoxazole and Trimethoprim | Sulfamethoxazole and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |