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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A088448-001 | DEXAMETHASONE | EQ 4MG PHOSPHATE/ML | INJECTABLE / INJECTION | 1984-01-25 | caaa826d4ba7… | ||
| 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… |
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 | DEXAMETHASONE | Amneal Pharmaceuticals NY LLC | ac71f888-c83a-46a5-921c-1ebdf6cfadc1 | 2024-02-21 | Warnings, Adverse reactions | dexamethasone |
| dexamethasone | DEXAMETHASONE | Amneal Pharmaceuticals NY LLC | b9eb9a30-c1da-4d38-8ea8-616a254e2afc | 2024-02-21 | Warnings, Adverse reactions | dexamethasone |
| Dexamethasone | DEXAMETHASONE | Alvogen Inc. | 9ab26af9-8196-e3d3-76a3-75227fd4e1c3 | 2024-02-21 | Warnings, Adverse reactions | Dexamethasone |
| DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | HF Acquisition Co LLC, DBA HealthFirst | 8e36534f-d64c-7e7b-e053-2995a90ad48e | 2024-01-30 | Warnings, Adverse reactions | DEXAMETHASONE SODIUM PHOSPHATE |
| DEXAMETHASONE | DEXAMETHASONE | Direct Rx | 3ff06262-4c6f-4423-99fa-b4d8191ea133 | 2024-01-09 | Warnings, Adverse reactions | DEXAMETHASONE |
| DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | HF Acquisition Co LLC, DBA HealthFirst | 7da9da65-0c03-23e2-e053-2a91aa0a042f | 2024-01-04 | Warnings, Adverse reactions | DEXAMETHASONE SODIUM PHOSPHATE |
| Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Medical Purchasing Solutions, LLC | 69339a97-99dd-7297-e053-2991aa0a7fb8 | 2023-06-22 | Warnings, Adverse reactions | DEXAMETHASONE SODIUM PHOSPHATE |
| DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | Medical Purchasing Solutions, LLC | 69346605-dff6-1958-e053-2a91aa0a0e1a | 2023-05-23 | Warnings, Adverse reactions | DEXAMETHASONE SODIUM PHOSPHATE |
| Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Medical Purchasing Solutions, LLC | 69344707-904d-7ba2-e053-2a91aa0a31f4 | 2023-05-23 | Warnings, Adverse reactions | DEXAMETHASONE SODIUM PHOSPHATE |
| DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | Medical Purchasing Solutions, LLC | 69485218-9330-952d-e053-2a91aa0ad4e8 | 2023-05-22 | Warnings, Adverse reactions | DEXAMETHASONE SODIUM PHOSPHATE |
| Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Medical Purchasing Solutions, LLC | 86091483-2053-5da8-e053-2a91aa0a6f45 | 2023-05-16 | Warnings, Adverse reactions | DEXAMETHASONE SODIUM PHOSPHATE |
| Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Medical Purchasing Solutions, LLC | 81a28bdb-b186-8047-e053-2a91aa0a4e0a | 2023-05-16 | Warnings, Adverse reactions | DEXAMETHASONE SODIUM PHOSPHATE |
| Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Medical Purchasing Solutions, LLC | 81a0503c-39fe-1c67-e053-2a91aa0a5b8f | 2023-05-16 | Warnings, Adverse reactions | DEXAMETHASONE SODIUM PHOSPHATE |
| Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Medical Purchasing Solutions, LLC | 8effed8e-9a75-eb3e-e053-2a95a90a965b | 2023-05-15 | Warnings, Adverse reactions | DEXAMETHASONE SODIUM PHOSPHATE |
| Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Medical Purchasing Solutions, LLC | 8969803e-2e45-1f28-e053-2995a90a05a7 | 2023-05-15 | Warnings, Adverse reactions | DEXAMETHASONE SODIUM PHOSPHATE |
| Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Medical Purchasing Solutions, LLC | bbf0f0ee-1891-4f3d-e053-2a95a90a5e18 | 2023-05-04 | Warnings, Adverse reactions | DEXAMETHASONE SODIUM PHOSPHATE |
| DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | Medical Purchasing Solutions, LLC | 9f69846e-5897-c301-e053-2a95a90a44f1 | 2023-05-03 | Warnings, Adverse reactions | DEXAMETHASONE SODIUM PHOSPHATE |
| DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | Medical Purchasing Solutions, LLC | 667323ea-5a5e-3465-e053-2a91aa0a1667 | 2023-04-26 | Warnings, Adverse reactions | DEXAMETHASONE SODIUM PHOSPHATE |
| Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Asclemed USA, Inc. | 2d96d5e8-00bf-406b-b345-f1c31865fe94 | 2023-04-04 | Warnings, Adverse reactions | DEXAMETHASONE SODIUM PHOSPHATE |
| DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | HF Acquisition Co LLC, DBA HealthFirst | 94cb045b-5801-db32-e053-2a95a90a93ef | 2022-12-10 | Warnings, Adverse reactions | DEXAMETHASONE SODIUM PHOSPHATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.