Application 018564
- Type
- NDA
- Sponsor
- ICU MEDICAL INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEXTROSE 20% IN PLASTIC CONTAINER | DEXTROSE | INJECTABLE;INJECTION | 20GM/100ML | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018564-001 | DEXTROSE 20% IN PLASTIC CONTAINER | DEXTROSE | 20GM/100ML | INJECTABLE / INJECTION | RLD, RS | 1982-03-23 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N018564-001 | DEXTROSE 20% IN PLASTIC CONTAINER | 20GM/100ML | INJECTABLE / INJECTION | RLD, RS | 1982-03-23 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N018564-001 | DEXTROSE 20% IN PLASTIC CONTAINER | 20GM/100ML | INJECTABLE / INJECTION | RLD, RS | 1982-03-23 | 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 |
|---|---|---|---|---|---|---|
| Dextrose | DEXTROSE | ICU Medical Inc. | b5cb7a5a-bbe8-4217-a82e-da818f7771c9 | 2025-11-02 | Warnings, Adverse reactions | 018564 NDA018564 0990-7935 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0409-7935 | Dextrose | dextrose | Hospira, Inc. | NDA | Current |
| 0409-7935 | Dextrose | dextrose | Hospira, Inc. | NDA | Current |
| 0990-7935 | Dextrose | dextrose | ICU Medical Inc. | NDA | Current |
| 0990-7935 | Dextrose | dextrose | ICU Medical Inc. | NDA | Current |
| 0990-7935 | Dextrose | dextrose | ICU Medical Inc. | NDA | Current |
| 0990-7935 | Dextrose | dextrose | ICU Medical Inc. | NDA | Current |