Application 218469
- Type
- ANDA
- Sponsor
- AMNEAL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SODIUM ACETATE | SODIUM ACETATE | SOLUTION;INTRAVENOUS | 100MEQ/50ML (2MEQ/ML) | No | No |
| 002 | SODIUM ACETATE | SODIUM ACETATE | SOLUTION;INTRAVENOUS | 200MEQ/100ML (2MEQ/ML) | No | No |
| 003 | SODIUM ACETATE | SODIUM ACETATE | SOLUTION;INTRAVENOUS | 40MEQ/20ML (2MEQ/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A218469-001 | SODIUM ACETATE | SODIUM ACETATE | 100MEQ/50ML (2MEQ/ML) | SOLUTION / INTRAVENOUS | AP | 2025-08-08 | |
| A218469-002 | SODIUM ACETATE | SODIUM ACETATE | 200MEQ/100ML (2MEQ/ML) | SOLUTION / INTRAVENOUS | AP | 2025-08-08 | |
| A218469-003 | SODIUM ACETATE | SODIUM ACETATE | 40MEQ/20ML (2MEQ/ML) | SOLUTION / INTRAVENOUS | AP | 2026-03-02 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A218469-001 | AP |
| A218469-002 | AP |
| A218469-003 | AP |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A218469-001 | SODIUM ACETATE | 100MEQ/50ML (2MEQ/ML) | SOLUTION / INTRAVENOUS | AP | 2025-08-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A218469-002 | SODIUM ACETATE | 200MEQ/100ML (2MEQ/ML) | SOLUTION / INTRAVENOUS | AP | 2025-08-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A218469-003 | SODIUM ACETATE | 40MEQ/20ML (2MEQ/ML) | SOLUTION / INTRAVENOUS | AP | 2026-03-02 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218469-001 | SODIUM ACETATE | 100MEQ/50ML (2MEQ/ML) | SOLUTION / INTRAVENOUS | AP | 2025-08-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218469-002 | SODIUM ACETATE | 200MEQ/100ML (2MEQ/ML) | SOLUTION / INTRAVENOUS | AP | 2025-08-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218469-001 | SODIUM ACETATE | 100MEQ/50ML (2MEQ/ML) | SOLUTION / INTRAVENOUS | AP | 2025-08-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218469-002 | SODIUM ACETATE | 200MEQ/100ML (2MEQ/ML) | SOLUTION / INTRAVENOUS | AP | 2025-08-08 | 31067a03dcf5… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218469-001 | SODIUM ACETATE | 100MEQ/50ML (2MEQ/ML) | SOLUTION / INTRAVENOUS | AP | 2025-08-08 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218469-002 | SODIUM ACETATE | 200MEQ/100ML (2MEQ/ML) | SOLUTION / INTRAVENOUS | AP | 2025-08-08 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218469-003 | SODIUM ACETATE | 40MEQ/20ML (2MEQ/ML) | SOLUTION / INTRAVENOUS | AP | 2026-03-02 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A218469-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A218469-002 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A218469-003 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A218469-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218469-002 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218469-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218469-002 | AP | 1 | 31067a03dcf5… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218469-001 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218469-002 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218469-003 | AP | 1 | a50c72e98297… |
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 Acetate | SODIUM ACETATE | Amneal Pharmaceuticals Private Limited | 0c0b11da-d7fc-4b4c-b0ef-d97af8e88abf | 2026-08-21 | Warnings, Adverse reactions | 218469 ANDA218469 |
| SODIUM ACETATE | SODIUM ACETATE | Amneal Pharmaceuticals Private Limited | 338105c0-c645-4b84-a125-4e1ead92b840 | 2025-08-11 | Warnings, Adverse reactions | 218469 ANDA218469 |