Application 088448
- Type
- ANDA
- Sponsor
- ABRAXIS PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEXAMETHASONE | DEXAMETHASONE SODIUM PHOSPHATE | INJECTABLE;INJECTION | EQ 4MG PHOSPHATE/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A088448-001 | DEXAMETHASONE | DEXAMETHASONE SODIUM PHOSPHATE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 |
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 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | 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 |
|---|---|---|---|---|---|---|
| Dexamethasone sodium phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Micro Labs Limited | c6f2563b-5a39-48bf-bcfe-71dd417bd970 | 2026-08-01 | Warnings, Adverse reactions | DEXAMETHASONE SODIUM PHOSPHATE |
| Dexamethasone | DEXAMETHASONE | Sportpharm LLC | a37486b9-4323-41fc-ac7e-869d95dc9568 | 2026-07-17 | Warnings, Adverse reactions | Dexamethasone |
| Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Sportpharm LLC | a8aee11f-c928-41ef-8df8-e6d8b355536c | 2026-07-10 | Warnings, Adverse reactions | DEXAMETHASONE SODIUM PHOSPHATE |
| Dexamethasone | DEXAMETHASONE | REMEDYREPACK INC. | f5c9b70b-b835-4f3b-9643-0aec50a0d3f2 | 2026-07-07 | Warnings, Adverse reactions | Dexamethasone |
| Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Fresenius Kabi USA, LLC | cca2c160-9188-48e8-9505-49a52388dcb7 | 2026-06-30 | Warnings, Adverse reactions | DEXAMETHASONE SODIUM PHOSPHATE |
| Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Fresenius Kabi USA, LLC | 7cbd9005-7df2-47ee-adb3-7244c1c69bc3 | 2026-06-30 | Warnings, Adverse reactions | DEXAMETHASONE SODIUM PHOSPHATE |
| Dexamethasone | DEXAMETHASONE | Pangea Pharmaceuticals, LLC | a41e6e26-9ebb-4b06-866e-a24af21c644c | 2026-06-29 | Warnings, Adverse reactions | Dexamethasone |
| Dexamethasone | DEXAMETHASONE | PD-Rx Pharmaceuticals, Inc. | 89e1d458-7caa-430f-9c54-360889899a73 | 2026-06-12 | Warnings, Adverse reactions | Dexamethasone |
| Dexamethasone | DEXAMETHASONE | PD-Rx Pharmaceuticals, Inc. | 736861fa-1df8-4afd-ba4a-dd7d7bffd865 | 2026-06-12 | Warnings, Adverse reactions | Dexamethasone |
| Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Fresenius Kabi USA, LLC | 2b626a48-c7aa-4443-9164-a08ff069ccd1 | 2026-06-08 | Warnings, Adverse reactions | DEXAMETHASONE SODIUM PHOSPHATE |
| Dexamethasone | DEXAMETHASONE | Preferred Pharmaceuticals Inc | 79b65fd4-16a5-42e0-b041-61d7bda0a5ff | 2026-06-08 | Warnings, Adverse reactions | Dexamethasone |
| Dexamethasone | DEXAMETHASONE | REMEDYREPACK INC. | 8deaaaf7-3efd-4065-b29f-e5ef038030f8 | 2026-06-01 | Warnings, Adverse reactions | Dexamethasone |
| Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Cardinal Health 107, LLC | 6d3cbd54-93ef-40fe-b15a-7a4f52dc5f71 | 2026-05-29 | Warnings, Adverse reactions | DEXAMETHASONE SODIUM PHOSPHATE |
| Dexamethasone | DEXAMETHASONE | Cardinal Health 107, LLC | bf8acfdb-8dc8-4a69-90b0-33c680c421d6 | 2026-05-15 | Warnings, Adverse reactions | Dexamethasone |
| dexamethasone | DEXAMETHASONE | Cardinal Health 107, LLC | 5622f8d2-1893-441b-8011-fa90c8a63b0b | 2026-05-05 | Warnings, Adverse reactions | dexamethasone |
| Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Sportpharm LLC | 6c7ff5f7-5688-4fc4-9194-9e6b8e6fab59 | 2026-04-24 | Warnings, Adverse reactions | DEXAMETHASONE SODIUM PHOSPHATE |
| Dexamethasone | DEXAMETHASONE | Sportpharm LLC | 12d19271-867b-41ae-a6d2-7e8de3637011 | 2026-04-24 | Warnings, Adverse reactions | Dexamethasone |
| Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Cardinal Health 107, LLC | 7a7ee007-cd02-4f3f-8f0f-82c4964da6e6 | 2026-04-21 | Warnings, Adverse reactions | DEXAMETHASONE SODIUM PHOSPHATE |
| Dexamethasone | DEXAMETHASONE | Pangea Pharmaceuticals, LLC | 37607468-0331-44c0-9bb4-5c614c7b69d4 | 2026-04-19 | Warnings, Adverse reactions | Dexamethasone |
| Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | REMEDYREPACK INC. | 1596a3b4-8c2c-41b4-b1eb-af09863eaa13 | 2026-04-15 | Warnings, Adverse reactions | DEXAMETHASONE SODIUM PHOSPHATE |