Application 062455
- Type
- ANDA
- Sponsor
- PADDOCK LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | POLYMYXIN B SULFATE | POLYMYXIN B SULFATE | POWDER;FOR RX COMPOUNDING | 100,000,000 UNITS/BOT | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A062455-001 | POLYMYXIN B SULFATE | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A062455-001 | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER / FOR RX COMPOUNDING | 1983-07-27 | cb3db0bc1861… |
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 | POLYMYXIN B SULFATE | Xellia Pharmaceuticals USA LLC | b56f18c0-ef5e-4ed9-a5af-f79f3cd189b6 | 2026-06-22 | Boxed warning, Warnings, Adverse reactions | POLYMYXIN B SULFATE |
| Polymyxin B | POLYMYXIN B SULFATE | Sagent Pharmaceuticals | 7dc505aa-64b0-4b7f-8ee3-2945bde40a34 | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | POLYMYXIN B SULFATE |
| POLYMYXIN B | POLYMYXIN B SULFATE | FOSUN PHARMA USA INC | fd664927-db58-a1af-e053-6294a90a9048 | 2025-05-29 | Boxed warning, Warnings, Adverse reactions | POLYMYXIN B SULFATE |
| Polymyxin B | POLYMYXIN B SULFATE | Hikma Pharmaceuticals USA Inc. | d2bf65f6-2763-4859-a665-ad5e6cde71ee | 2025-05-23 | Boxed warning, Warnings, Adverse reactions | POLYMYXIN B SULFATE |
| POLYMYXIN B | POLYMYXIN B SULFATE | Gland Pharma Limited | dc74dee2-1d0b-4fab-a29b-1755fdb5da75 | 2025-05-09 | Boxed warning, Warnings, Adverse reactions | POLYMYXIN B SULFATE |
| Polymyxin B | POLYMYXIN B SULFATE | Fresenius Kabi USA, LLC | 72dd6de6-31d6-4a8f-881b-91af91ed9314 | 2022-12-01 | Boxed warning, Warnings, Adverse reactions | POLYMYXIN B SULFATE |
| Polymyxin B | POLYMYXIN B SULFATE | Hikma Pharmaceuticals USA Inc. | 18daf0d1-b6f5-46f4-ab2f-01a594f3959c | 2022-04-28 | Boxed warning, Warnings, Adverse reactions | POLYMYXIN B SULFATE |
| POLYMYXIN B | POLYMYXIN B SULFATE | Fresenius Kabi USA, LLC | 704a41f5-b109-4c16-8d3e-1495c9917952 | 2021-05-31 | Boxed warning, Warnings, Adverse reactions | POLYMYXIN B SULFATE |
| POLYMYXIN B | POLYMYXIN B SULFATE | Fresenius Kabi USA, LLC | fbc12c18-567b-41bc-89d0-efd29616615c | 2021-02-28 | Boxed warning, Warnings, Adverse reactions | POLYMYXIN B SULFATE |