Application 017586
- Type
- NDA
- Sponsor
- ICU MEDICAL INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NORMOSOL-R IN PLASTIC CONTAINER | MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE | INJECTABLE;INJECTION | 30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N017586-001 | NORMOSOL-R IN PLASTIC CONTAINER | MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE | 30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE / INJECTION | Approved before 1982 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | N017586-001 | NORMOSOL-R IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE / INJECTION | Approved before 1982 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N017586-001 | NORMOSOL-R IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE / INJECTION | Approved before 1982 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N017586-001 | NORMOSOL-R IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE / INJECTION | Approved before 1982 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N017586-001 | NORMOSOL-R IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100ML | INJECTABLE / INJECTION | Approved before 1982 | 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 |
|---|---|---|---|---|---|---|
| Normosol-R | SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | ICU Medical Inc. | 0e089a44-0cee-4804-8f6f-8508508ddb5c | 2025-10-30 | Warnings, Adverse reactions | 017586 NDA017586 0990-7670 |
| Normosol-R | SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | ICU Medical Inc. | 189b8ac6-e346-454f-b501-7645590ca4f8 | 2025-10-29 | Warnings, Adverse reactions | 017586 NDA017586 0990-7967 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0409-7670 | Normosol-R | SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-7670 | Normosol-R | SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-7670 | Normosol-R | SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-7967 | Normosol-R | SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-7967 | Normosol-R | SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-7967 | Normosol-R | SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-7967 | Normosol-R | SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | Hospira, Inc. | NDA | Current |
| 0990-7670 | Normosol-R | SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | ICU Medical Inc. | NDA | Current |
| 0990-7670 | Normosol-R | SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | ICU Medical Inc. | NDA | Current |
| 0990-7670 | Normosol-R | SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | ICU Medical Inc. | NDA | Current |
| 0990-7670 | Normosol-R | SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | ICU Medical Inc. | NDA | Current |
| 0990-7670 | Normosol-R | SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | ICU Medical Inc. | NDA | Current |
| 0990-7967 | Normosol-R | SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | ICU Medical Inc. | NDA | Current |
| 0990-7967 | Normosol-R | SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | ICU Medical Inc. | NDA | Current |
| 0990-7967 | Normosol-R | SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | ICU Medical Inc. | NDA | Current |
| 0990-7967 | Normosol-R | SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | ICU Medical Inc. | NDA | Current |