Drug application
EXOSURF NEONATAL (CETYL ALCOHOL, COLFOSCERIL PALMITATE, TYLOXAPOL)
Drugs@FDA NDA 020044 · GLAXOSMITHKLINE
Key facts
| Drug name | EXOSURF NEONATAL |
|---|---|
| Active ingredients | CETYL ALCOHOL, COLFOSCERIL PALMITATE, TYLOXAPOL |
| Application type | NDA |
| Application number | 020044 |
| Company | GLAXOSMITHKLINE |
| Dosage forms | FOR SUSPENSION, INTRATRACHEAL |
| Strength | 12MG/VIAL;108MG/VIAL;8MG/VIAL |
| Marketing status | Discontinued |
| Reference listed drug | No |
| Latest submission class | Type 1 - New Molecular Entity and Type 4 - New Combination |
| Latest submission status date | Aug 2, 1990 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- None Label versions
- 1–9 Products
- None Therapeutic equivalents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.