Application 217594
- Type
- ANDA
- Sponsor
- STERISCIENCE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SODIUM BICARBONATE | SODIUM BICARBONATE | SOLUTION;INTRAVENOUS | 50MEQ/50ML (1MEQ/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A217594-001 | SODIUM BICARBONATE | SODIUM BICARBONATE | 50MEQ/50ML (1MEQ/ML) | SOLUTION / INTRAVENOUS | AP | 2023-06-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A217594-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A217594-001 | SODIUM BICARBONATE | 50MEQ/50ML (1MEQ/ML) | SOLUTION / INTRAVENOUS | AP | 2023-06-28 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A217594-001 | AP | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| SODIUM BICARBONATE | SODIUM BICARBONATE | Medical Purchasing Solutions, LLC | 4f97d398-2118-0874-e063-6394a90a4ad1 | 2026-04-16 | Warnings, Adverse reactions | 217594 ANDA217594 |
| SODIUM BICARBONATE | SODIUM BICARBONATE | ProPharma Distribution | 3867f743-c2cf-a646-e063-6394a90a82e1 | 2025-12-18 | Warnings, Adverse reactions | 217594 ANDA217594 |
| SODIUM BICARBONATE | SODIUM BICARBONATE | Sun Pharmaceutical Industries Limited | 5ae65432-04a1-4b6b-8536-2535064fc782 | 2024-03-06 | Warnings, Adverse reactions | 217594 ANDA217594 |
| Sodium Bicarbonate | SODIUM BICARBONATE | Steriscience Specialties Private Limited | eb2996b4-c04c-4678-b8a9-5cbbe509bb70 | 2024-03-04 | Warnings, Adverse reactions | 217594 ANDA217594 |