Application 202832
- Type
- NDA
- Sponsor
- MEDEFIL INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | INJECTABLE;INJECTION | 9MG/ML (9MG/ML) | Yes | No |
| 002 | SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | INJECTABLE;INJECTION | 18MG/2ML (9MG/ML) | Yes | No |
| 003 | SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | INJECTABLE;INJECTION | 22.5MG/2.5ML (9MG/ML) | Yes | No |
| 004 | SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | INJECTABLE;INJECTION | 27MG/3ML (9MG/ML) | Yes | No |
| 005 | SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | INJECTABLE;INJECTION | 45MG/5ML (9MG/ML) | Yes | No |
| 006 | SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | INJECTABLE;INJECTION | 90MG/10ML (9MG/ML) | Yes | No |