Application 217766
- Type
- NDA
- Sponsor
- LONG GROVE PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VASOPRESSIN IN SODIUM CHLORIDE 0.9% | VASOPRESSIN | SOLUTION;INTRAVENOUS | 20UNITS/100ML (0.2UNITS/ML) | Yes | Yes |
| 002 | VASOPRESSIN IN SODIUM CHLORIDE 0.9% | VASOPRESSIN | SOLUTION;INTRAVENOUS | 40UNITS/100ML (0.4UNITS/ML) | Yes | Yes |
| 003 | VASOPRESSIN IN SODIUM CHLORIDE 0.9% | VASOPRESSIN | SOLUTION;INTRAVENOUS | 50UNITS/50ML (1UNIT/ML) | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N217766-001 | VASOPRESSIN IN SODIUM CHLORIDE 0.9% | VASOPRESSIN | 20UNITS/100ML (0.2UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-07-11 | |
| N217766-002 | VASOPRESSIN IN SODIUM CHLORIDE 0.9% | VASOPRESSIN | 40UNITS/100ML (0.4UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-07-11 | |
| N217766-003 | VASOPRESSIN IN SODIUM CHLORIDE 0.9% | VASOPRESSIN | 50UNITS/50ML (1UNIT/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2024-07-11 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N217766-002 | VASOPRESSIN IN SODIUM CHLORIDE 0.9% | 40UNITS/100ML (0.4UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-07-11 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N217766-003 | VASOPRESSIN IN SODIUM CHLORIDE 0.9% | 50UNITS/50ML (1UNIT/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-07-11 | 79d66fd596c7… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217766-001 | VASOPRESSIN IN SODIUM CHLORIDE 0.9% | 20UNITS/100ML (0.2UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-07-11 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217766-002 | VASOPRESSIN IN SODIUM CHLORIDE 0.9% | 40UNITS/100ML (0.4UNITS/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2024-07-11 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217766-003 | VASOPRESSIN IN SODIUM CHLORIDE 0.9% | 50UNITS/50ML (1UNIT/ML) | SOLUTION / INTRAVENOUS | RLD | 2024-07-11 | 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 |
|---|---|---|---|---|---|---|
| Vasopressin in 0.9% Sodium Chloride | VASOPRESSIN | Long Grove Pharmaceuticals, LLC | bf4b0b63-0055-40d8-b331-7f9f1ea3214c | 2025-06-17 | Warnings, Adverse reactions | 217766 NDA217766 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.