Application 016733
- 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 | SOLUTION;IRRIGATION | 900MG/100ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0264-2201 | Sodium Chloride | Sodium Chloride | B. Braun Medical Inc. | NDA | Current |
| 0264-2201 | Sodium Chloride | Sodium Chloride | B. Braun Medical Inc. | NDA | Current |
| 0264-7388 | Sodium Chloride for Irrigation | Sodium Chloride for Irrigation | B. Braun Medical Inc. | NDA | Current |
| 0264-7388 | Sodium Chloride for Irrigation | Sodium Chloride for Irrigation | B. Braun Medical Inc. | NDA | Current |
| 61786-217 | Sodium Chloride | Sodium Chloride | REMEDYREPACK INC. | NDA | Current |