Application 018895
- Type
- NDA
- Sponsor
- HOSPIRA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TPN ELECTROLYTES IN PLASTIC CONTAINER | CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE | INJECTABLE;INJECTION | 16.5MG/ML;25.4MG/ML;74.6MG/ML;121MG/ML;16.1MG/ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0409-5779 | TPN Electrolytes | SODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, and SODIUM ACETATE ANHYDROUS | Hospira, Inc. | NDA | Current |
| 0409-5779 | TPN Electrolytes | SODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, and SODIUM ACETATE ANHYDROUS | Hospira, Inc. | NDA | Current |
| 0409-5779 | TPN Electrolytes | SODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, and SODIUM ACETATE ANHYDROUS | Hospira, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 16085 | SUPPL | 2003-05-29 |