General MedicationsINTRATRACHEALGeneric

EXOSURF NEONATAL

CETYL ALCOHOL; COLFOSCERIL PALMITATE; TYLOXAPOL

Standard Dose

12MG/VIAL;108MG/VIAL;8MG/VIAL

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Discontinued

Summary

Approval overview EXOSURF NEONATAL is listed in Drugs@FDA under application 020044 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient CETYL ALCOHOL; COLFOSCERIL PALMITATE; TYLOXAPOL Form and strength FOR SUSPENSION;INTRATRACHEAL - 12MG/VIAL;108MG/VIAL;8MG/VIAL Sponsor GLAXOSMITHKLINE Submission history Latest submission status date: 2000-11-21 00:00:00.

Structured Monograph

Clinical summary

Approval overview EXOSURF NEONATAL is listed in Drugs@FDA under application 020044 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient CETYL ALCOHOL; COLFOSCERIL PALMITATE; TYLOXAPOL Form and strength FOR SUSPENSION;INTRATRACHEAL - 12MG/VIAL;108MG/VIAL;8MG/VIAL Sponsor GLAXOSMITHKLINE Submission history Latest submission status date: 2000-11-21 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.