Application 202090
- Type
- ANDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SODIUM OXYBATE | SODIUM OXYBATE | SOLUTION;ORAL | 500MG/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202090-001 | SODIUM OXYBATE | SODIUM OXYBATE | 0.5GM/ML | SOLUTION / ORAL | 2017-01-17 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | A202090-001 | SODIUM OXYBATE | 0.5GM/ML | SOLUTION / ORAL | 2017-01-17 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A202090-001 | SODIUM OXYBATE | 0.5GM/ML | SOLUTION / ORAL | 2017-01-17 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A202090-001 | SODIUM OXYBATE | 0.5GM/ML | SOLUTION / ORAL | 2017-01-17 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A202090-001 | SODIUM OXYBATE | 0.5GM/ML | SOLUTION / ORAL | 2017-01-17 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A202090-001 | AA | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A202090-001 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A202090-001 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A202090-001 | AA | 1 | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| sodium oxybate | SODIUM OXYBATE | Camber Pharmaceuticals, Inc. | 5dcf9a5c-312b-420b-82f3-42177d8f9ee4 | 2026-04-21 | Boxed warning, Warnings, Adverse reactions | sodium oxybate SODIUM OXYBATE |
| sodium oxybate | SODIUM OXYBATE | XLCare Pharmaceuticals, Inc. | c0fb2620-7247-464d-a37a-8b516ce7d563 | 2026-01-06 | Boxed warning, Warnings, Adverse reactions | sodium oxybate SODIUM OXYBATE |
| Xyrem | SODIUM OXYBATE | Jazz Pharmaceuticals, Inc. | 926eb076-a4a8-45e4-91ef-411f0aa4f3ca | 2025-07-01 | Boxed warning, Warnings, Adverse reactions | SODIUM OXYBATE |
| Sodium Oxybate | SODIUM OXYBATE | Amneal Pharmaceuticals LLC | 5a9e9045-f04d-46eb-8396-2495c6090a31 | 2025-05-19 | Boxed warning, Warnings, Adverse reactions | Sodium Oxybate SODIUM OXYBATE |
| sodium oxybate | SODIUM OXYBATE | Hikma Pharmaceuticals USA Inc. | bcef2c95-35e9-464d-9025-652acff769e7 | 2023-04-25 | Boxed warning, Warnings, Adverse reactions | sodium oxybate SODIUM OXYBATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.