Application 215320
- Type
- NDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | COMBOGESIC IV | ACETAMINOPHEN; IBUPROFEN SODIUM | SOLUTION;INTRAVENOUS | 1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) | Yes | Yes |