Application 017464
- Type
- NDA
- Sponsor
- B BRAUN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | INJECTABLE;INJECTION | 900MG/100ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0264-1800 | Sodium Chloride | Sodium Chloride | B. Braun Medical Inc. | NDA | Current |
| 0264-1800 | Sodium Chloride | Sodium Chloride | B. Braun Medical Inc. | NDA | Current |
| 70529-021 | Nacellate Solution 0.9% - 100mL | Sodium Chloride | IT3 Medical LLC | NDA | Current |
| 70529-021 | Nacellate Solution 0.9% - 100mL | Sodium Chloride | IT3 Medical LLC | NDA | Current |
| 70529-021 | Nacellate Solution 0.9% - 100mL | Sodium Chloride | IT3 Medical LLC | NDA | Current |