Application 018897
- Type
- NDA
- Sponsor
- HOSPIRA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SODIUM CHLORIDE IN PLASTIC CONTAINER | SODIUM CHLORIDE | INJECTABLE;INJECTION | 2.5MEQ/ML | Yes | No |
| 002 | SODIUM CHLORIDE 14.6% | SODIUM CHLORIDE | SOLUTION;INTRAVENOUS | 100MEQ/40ML (2.5MEQ/ML) | Yes | No |
| 003 | SODIUM CHLORIDE 23.4% | SODIUM CHLORIDE | SOLUTION;INTRAVENOUS | 400MEQ/100ML (4MEQ/ML) | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0409-1141 | SODIUM CHLORIDE | SODIUM CHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1141 | SODIUM CHLORIDE | SODIUM CHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-1141 | SODIUM CHLORIDE | SODIUM CHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-6660 | Sodium Chloride | SODIUM CHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-6660 | Sodium Chloride | SODIUM CHLORIDE | Hospira, Inc. | NDA | Current |
| 0409-6660 | Sodium Chloride | SODIUM CHLORIDE | Hospira, Inc. | NDA | Current |