Application 020044
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EXOSURF NEONATAL | CETYL ALCOHOL; COLFOSCERIL PALMITATE; TYLOXAPOL | FOR SUSPENSION;INTRATRACHEAL | 12MG/VIAL;108MG/VIAL;8MG/VIAL | No | No |