Application 064211
- Type
- ANDA
- Sponsor
- SANDOZ INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE | SOLUTION/DROPS;OPHTHALMIC | 10,000 UNITS/ML;EQ 1MG BASE/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A064211-001 | AT |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | 1998-04-13 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | 1998-04-13 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | 1998-04-13 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | 1998-04-13 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | 1998-04-13 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | 1998-04-13 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | 1998-04-13 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | 1998-04-13 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | 1998-04-13 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | 1998-04-13 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | 1998-04-13 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | 1998-04-13 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | 1998-04-13 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | 1998-04-13 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | 1998-04-13 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | 1998-04-13 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | 1998-04-13 | e64feba35796… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A064211-001 | AT | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A064211-001 | AT | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A064211-001 | AT | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A064211-001 | AT | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A064211-001 | AT | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A064211-001 | AT | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A064211-001 | AT | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A064211-001 | AT | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A064211-001 | AT | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A064211-001 | AT | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A064211-001 | AT | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A064211-001 | AT | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A064211-001 | AT | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A064211-001 | AT | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A064211-001 | AT | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A064211-001 | AT | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A064211-001 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A064211-001 | AT | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A064211-001 | AT | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A064211-001 | AT | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A064211-001 | AT | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A064211-001 | AT | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A064211-001 | AT | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A064211-001 | AT | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A064211-001 | AT | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A064211-001 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A064211-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A064211-001 | AT | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A064211-001 | AT | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A064211-001 | AT | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A064211-001 | AT | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A064211-001 | AT | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A064211-001 | AT | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A064211-001 | AT | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A064211-001 | AT | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A064211-001 | AT | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A064211-001 | AT | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A064211-001 | AT | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A064211-001 | AT | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A064211-001 | AT | 1 | e64feba35796… |
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 |
|---|---|---|---|---|---|---|
| Polymyxin B Sulfate and Trimethoprim | POLYMYXIN B SULFATE AND TRIMETHOPRIM | Preferred Pharmacetucials Inc. | 65293418-c6ad-43d8-948c-e1949c0afc31 | 2026-08-17 | Warnings, Adverse reactions | 064211 ANDA064211 68788-6927 |
| Polymyxin B Sulfate and Trimethoprim | POLYMYXIN B SULFATE AND TRIMETHOPRIM | A-S Medication Solutions | aaa468d2-470f-43cf-b4e2-68aeb94a1e71 | 2026-02-03 | Warnings, Adverse reactions | 064211 ANDA064211 50090-2925 |
| Polymyxin B Sulfate and Trimethoprim | POLYMYXIN B SULFATE AND TRIMETHOPRIM | REMEDYREPACK INC. | 2a040ba4-54bd-41e4-b519-01ca6a59658f | 2026-01-27 | Warnings, Adverse reactions | 064211 ANDA064211 70518-1735 |
| Polymyxin B Sulfate and Trimethoprim | POLYMYXIN B SULFATE AND TRIMETHOPRIM | Sandoz Inc | 71900075-5288-4f4b-afe2-098436fa2173 | 2025-09-05 | Warnings, Adverse reactions | 064211 ANDA064211 61314-628 |
| Polymyxin B Sulfate and Trimethoprim | POLYMYXIN B SULFATE AND TRIMETHOPRIM | NuCare Pharmaceuticals,Inc. | 60f5cfcf-cdb2-0e45-e053-2991aa0ae85a | 2024-07-18 | Warnings, Adverse reactions | 064211 ANDA064211 68071-4103 |
| Polymyxin B Sulfate and Trimethoprim | POLYMYXIN B SULFATE AND TRIMETHOPRIM | Proficient Rx LP | 1252b997-3a81-4f3c-90e4-92f29ba15713 | 2022-04-01 | Warnings, Adverse reactions | 064211 ANDA064211 63187-834 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 21695-335 | Polymyxin B Sulfate and Trimethoprim | polymyxin B sulfate and trimethoprim | Rebel Distributors Corp | ANDA | Current |
| 50090-2925 | Polymyxin B Sulfate and Trimethoprim | Polymyxin B Sulfate and Trimethoprim | A-S Medication Solutions | ANDA | Current |
| 50090-2925 | Polymyxin B Sulfate and Trimethoprim | Polymyxin B Sulfate and Trimethoprim | A-S Medication Solutions | ANDA | Current |
| 53002-8621 | Polymyxin B Sulfate and Trimethoprim | Polymyxin B Sulfate and Trimethoprim | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-8621 | Polymyxin B Sulfate and Trimethoprim | Polymyxin B Sulfate and Trimethoprim | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53217-305 | Polymyxin B Sulfate and Trimethoprim | Polymyxin B Sulfate and Trimethoprim | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 61314-628 | Polymyxin B Sulfate and Trimethoprim | Polymyxin B Sulfate and Trimethoprim | Sandoz Inc | ANDA | Current |
| 61314-628 | Polymyxin B Sulfate and Trimethoprim | Polymyxin B Sulfate and Trimethoprim | Sandoz Inc | ANDA | Current |
| 61314-628 | Polymyxin B Sulfate and Trimethoprim | Polymyxin B Sulfate and Trimethoprim | Sandoz Inc | ANDA | Current |
| 61919-115 | POLYMYXIN B SULFATE AND TRIMETHOPRIM | POLYMYXIN B SULFATE AND TRIMETHOPRIM | DIRECT RX | ANDA | Current |
| 61919-215 | POLYMYXIN B SULFATE AND TRIMETHOPRIM | POLYMYXIN B SULFATE AND TRIMETHOPRIM | DIRECT RX | ANDA | Current |
| 63187-834 | Polymyxin B Sulfate and Trimethoprim | Polymyxin B Sulfate and Trimethoprim | Proficient Rx LP | ANDA | Current |
| 63187-834 | Polymyxin B Sulfate and Trimethoprim | Polymyxin B Sulfate and Trimethoprim | Proficient Rx LP | ANDA | Current |
| 63187-834 | Polymyxin B Sulfate and Trimethoprim | Polymyxin B Sulfate and Trimethoprim | Proficient Rx LP | ANDA | Current |
| 63187-834 | Polymyxin B Sulfate and Trimethoprim | Polymyxin B Sulfate and Trimethoprim | Proficient Rx LP | ANDA | Current |
| 68071-4103 | Polymyxin B Sulfate and Trimethoprim | Polymyxin B Sulfate and Trimethoprim | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4103 | Polymyxin B Sulfate and Trimethoprim | Polymyxin B Sulfate and Trimethoprim | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-6927 | Polymyxin B Sulfate and Trimethoprim | Polymyxin B Sulfate and Trimethoprim | Preferred Pharmacetucials Inc. | ANDA | Current |
| 68788-6927 | Polymyxin B Sulfate and Trimethoprim | Polymyxin B Sulfate and Trimethoprim | Preferred Pharmacetucials Inc. | ANDA | Current |
| 68788-6927 | Polymyxin B Sulfate and Trimethoprim | Polymyxin B Sulfate and Trimethoprim | Preferred Pharmacetucials Inc. | ANDA | Current |
| 68788-6927 | Polymyxin B Sulfate and Trimethoprim | Polymyxin B Sulfate and Trimethoprim | Preferred Pharmacetucials Inc. | ANDA | Current |
| 68788-6927 | Polymyxin B Sulfate and Trimethoprim | Polymyxin B Sulfate and Trimethoprim | Preferred Pharmacetucials Inc. | ANDA | Current |
| 70518-1735 | Polymyxin B Sulfate and Trimethoprim | Polymyxin B Sulfate and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-1735 | Polymyxin B Sulfate and Trimethoprim | Polymyxin B Sulfate and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-1735 | Polymyxin B Sulfate and Trimethoprim | Polymyxin B Sulfate and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-1735 | Polymyxin B Sulfate and Trimethoprim | Polymyxin B Sulfate and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-1735 | Polymyxin B Sulfate and Trimethoprim | Polymyxin B Sulfate and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |
| 70518-1735 | Polymyxin B Sulfate and Trimethoprim | Polymyxin B Sulfate and Trimethoprim | REMEDYREPACK INC. | ANDA | Current |