Application 019635
- Type
- NDA
- Sponsor
- B BRAUN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | SODIUM CHLORIDE | INJECTABLE;INJECTION | 450MG/100ML | Yes | No |
| 002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | INJECTABLE;INJECTION | 900MG/100ML | Yes | Yes |
| 003 | SODIUM CHLORIDE 3% IN PLASTIC CONTAINER | SODIUM CHLORIDE | INJECTABLE;INJECTION | 3GM/100ML | No | No |
| 004 | SODIUM CHLORIDE 5% IN PLASTIC CONTAINER | SODIUM CHLORIDE | INJECTABLE;INJECTION | 5GM/100ML | No | No |
| 005 | SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | INJECTABLE;INJECTION | 9MG/10ML | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0264-5802 | Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | NDA | Current |
| 0264-5804 | Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | NDA | Current |
| 0264-7800 | Sodium Chloride | Sodium Chloride | B. Braun Medical Inc. | NDA | Current |
| 0264-7800 | Sodium Chloride | Sodium Chloride | B. Braun Medical Inc. | NDA | Current |
| 0264-7800 | Sodium Chloride | Sodium Chloride | B. Braun Medical Inc. | NDA | Current |
| 0264-7800 | Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | NDA | Current |
| 0264-7800 | Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | NDA | Current |
| 0264-7800 | Sodium Chloride | Sodium Chloride | B. Braun Medical Inc. | NDA | Current |
| 0264-7800 | Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | NDA | Current |
| 0264-7800 | Sodium Chloride | Sodium Chloride | B. Braun Medical Inc. | NDA | Current |
| 0264-7800 | Sodium Chloride | Sodium Chloride | B. Braun Medical Inc. | NDA | Current |
| 0264-7800 | Sodium Chloride | Sodium Chloride | B. Braun Medical Inc. | NDA | Current |
| 0264-7802 | Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | NDA | Current |
| 0264-7802 | Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | NDA | Current |
| 0264-7802 | Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | NDA | Current |
| 0264-7805 | Sodium Chloride | Sodium Chloride | B. Braun Medical Inc. | NDA | Current |
| 0264-7805 | Sodium Chloride | Sodium Chloride | B. Braun Medical Inc. | NDA | Current |
| 0264-7806 | Sodium Chloride | Sodium Chloride | B. Braun Medical Inc. | NDA | Current |
| 0264-7806 | Sodium Chloride | Sodium Chloride | B. Braun Medical Inc. | NDA | Current |
| 0264-9375 | Sodium Chloride | Sodium Chloride | B. Braun Medical Inc. | NDA | Current |
| 0264-9375 | Sodium Chloride | Sodium Chloride | B. Braun Medical Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 11574 | SUPPL | 2014-09-09 |