Application 218475
- Type
- NDA
- Sponsor
- BAXTER HLTHCARE CORP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EPINEPHRINE BITARTRATE | SOLUTION;INTRAVENOUS | EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | Yes | Yes |
| 002 | EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EPINEPHRINE BITARTRATE | SOLUTION;INTRAVENOUS | EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N218475-001 | EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EPINEPHRINE BITARTRATE | EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2025-02-28 | |
| N218475-002 | EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EPINEPHRINE BITARTRATE | EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2026-03-16 |
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 | N218475-001 | EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD | 2025-02-28 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N218475-002 | EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2026-03-16 | 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 |
|---|---|---|---|---|---|---|
| epinephrine | EPINEPHRINE | Baxter Healthcare Corporation | 60efd409-3555-4182-a68d-1cd7bc0d1bfc | 2026-03-16 | Warnings, Adverse reactions | 218475 NDA218475 |