Application 019217
- Type
- NDA
- Sponsor
- ICU MEDICAL 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 | Yes | No |
| 002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | SOLUTION;INJECTION | 45MG/5ML (9MG/ML) | Yes | No |
| 003 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | SOLUTION;INJECTION | 90MG/10ML (9MG/ML) | Yes | No |
| 004 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | SOLUTION;INJECTION | 360MG/40ML (9MG/ML) | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 1254 | SUPPL | 2003-12-11 |