Application 014694
- Type
- NDA
- Sponsor
- ASPEN GLOBAL INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | HEXADROL | DEXAMETHASONE SODIUM PHOSPHATE | INJECTABLE;INJECTION | EQ 4MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | HEXADROL | DEXAMETHASONE SODIUM PHOSPHATE | INJECTABLE;INJECTION | EQ 10MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | HEXADROL | DEXAMETHASONE SODIUM PHOSPHATE | INJECTABLE;INJECTION | EQ 20MG PHOSPHATE/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N014694-002 | HEXADROL | DEXAMETHASONE SODIUM PHOSPHATE | EQ 4MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | ||
| N014694-003 | HEXADROL | DEXAMETHASONE SODIUM PHOSPHATE | EQ 10MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | ||
| N014694-004 | HEXADROL | DEXAMETHASONE SODIUM PHOSPHATE | EQ 20MG PHOSPHATE/ML | INJECTABLE / INJECTION | Approved before 1982 |
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 | N014694-002 | HEXADROL | EQ 4MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N014694-003 | HEXADROL | EQ 10MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N014694-004 | HEXADROL | EQ 20MG PHOSPHATE/ML | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N014694-002 | HEXADROL | EQ 4MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N014694-003 | HEXADROL | EQ 10MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N014694-004 | HEXADROL | EQ 20MG PHOSPHATE/ML | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N014694-002 | HEXADROL | EQ 4MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N014694-003 | HEXADROL | EQ 10MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N014694-004 | HEXADROL | EQ 20MG PHOSPHATE/ML | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N014694-002 | HEXADROL | EQ 4MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N014694-003 | HEXADROL | EQ 10MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N014694-004 | HEXADROL | EQ 20MG PHOSPHATE/ML | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N014694-002 | HEXADROL | EQ 4MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N014694-003 | HEXADROL | EQ 10MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N014694-004 | HEXADROL | EQ 20MG PHOSPHATE/ML | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N014694-002 | HEXADROL | EQ 4MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N014694-003 | HEXADROL | EQ 10MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N014694-004 | HEXADROL | EQ 20MG PHOSPHATE/ML | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N014694-002 | HEXADROL | EQ 4MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N014694-003 | HEXADROL | EQ 10MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N014694-004 | HEXADROL | EQ 20MG PHOSPHATE/ML | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N014694-002 | HEXADROL | EQ 4MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N014694-003 | HEXADROL | EQ 10MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N014694-004 | HEXADROL | EQ 20MG PHOSPHATE/ML | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N014694-002 | HEXADROL | EQ 4MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N014694-003 | HEXADROL | EQ 10MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N014694-004 | HEXADROL | EQ 20MG PHOSPHATE/ML | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N014694-002 | HEXADROL | EQ 4MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N014694-003 | HEXADROL | EQ 10MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N014694-004 | HEXADROL | EQ 20MG PHOSPHATE/ML | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N014694-002 | HEXADROL | EQ 4MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N014694-003 | HEXADROL | EQ 10MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N014694-004 | HEXADROL | EQ 20MG PHOSPHATE/ML | INJECTABLE / INJECTION | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N014694-002 | HEXADROL | EQ 4MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N014694-003 | HEXADROL | EQ 10MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N014694-004 | HEXADROL | EQ 20MG PHOSPHATE/ML | INJECTABLE / INJECTION | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N014694-002 | HEXADROL | EQ 4MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N014694-003 | HEXADROL | EQ 10MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N014694-004 | HEXADROL | EQ 20MG PHOSPHATE/ML | INJECTABLE / INJECTION | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N014694-002 | HEXADROL | EQ 4MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 301d65b070ca… |
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 | Somerset Therapeutics, LLC | 799028e2-c0e4-494f-89ff-1b786babc34a | 2024-12-19 | Warnings, Adverse reactions | DEXAMETHASONE SODIUM PHOSPHATE |
| Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Fresenius Kabi USA, LLC | 4fedef4f-ec96-4f36-b2f0-01e243e3b89e | 2024-10-14 | Warnings, Adverse reactions | DEXAMETHASONE SODIUM PHOSPHATE |
| DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | HF Acquisition Co LLC, DBA HealthFirst | df77fab1-f58c-46db-e053-2a95a90a5416 | 2024-10-08 | Warnings, Adverse reactions | DEXAMETHASONE SODIUM PHOSPHATE |
| Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Amneal Pharmaceuticals LLC | ddc82c42-2e6e-42a6-a30a-e41978e2f4da | 2024-08-14 | Warnings, Adverse reactions | DEXAMETHASONE SODIUM PHOSPHATE |
| Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Amneal Pharmaceuticals LLC | ba18ba23-9ea3-4ce1-84ae-74e9151bb6a4 | 2024-07-29 | Warnings, Adverse reactions | DEXAMETHASONE SODIUM PHOSPHATE |
| Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Gland Pharma Limited | c9d9ab76-6bc6-433d-aad7-8d49064ed745 | 2024-06-26 | Warnings, Adverse reactions | DEXAMETHASONE SODIUM PHOSPHATE |
| Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Phlow Corporation | 02d25ab8-8f51-452b-b944-f569fbae36fe | 2024-06-25 | Warnings, Adverse reactions | DEXAMETHASONE SODIUM PHOSPHATE |
| DEXAMETHASONE SODIUM PHOSPHATE | DEXAMETHASONE SODIUM PHOSPHATE | HF Acquisition Co LLC, DBA HealthFirst | 18a70010-6cc5-19e2-e063-6394a90a0ea6 | 2024-05-28 | Warnings, Adverse reactions | DEXAMETHASONE SODIUM PHOSPHATE |
| Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | A-S Medication Solutions | d21f3055-8a8a-4797-93e2-c8f582cbdae1 | 2024-04-11 | Warnings, Adverse reactions | DEXAMETHASONE SODIUM PHOSPHATE |
| Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Mylan Institutional LLC | dff598e8-e662-411f-978d-4ba3fb8ef7db | 2024-03-05 | Warnings, Adverse reactions | DEXAMETHASONE SODIUM PHOSPHATE |
| 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 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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.