APPLICATION
NDA020044
TYPE
NDA
ORIGINAL APPROVAL
1990-08-02
LATEST ACTION
2000-11-21
ROUTE
INTRATRACHEAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued
Products
EXOSURF NEONATALDiscontinued
CETYL ALCOHOL 12MG/VIAL, COLFOSCERIL PALMITATE 108MG/VIAL, TYLOXAPOL 8MG/VIAL · FOR SUSPENSION · INTRATRACHEAL
Approval history
2000-11-21Labeling · Supplement 4 · standardAP
1999-04-02Manufacturing (CMC) · Supplement 3 · priorityAP
1990-08-02Type 1 - New Molecular Entity and Type 4 - New Combination · Original · priorityAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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