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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020044

EXOSURF NEONATAL (CETYL ALCOHOL; COLFOSCERIL PALMITATE; TYLOXAPOL)
12MG/VIAL;108MG/VIAL;8MG/VIAL
Marketing Status: Discontinued
Active Ingredient: CETYL ALCOHOL; COLFOSCERIL PALMITATE; TYLOXAPOL
Proprietary Name: EXOSURF NEONATAL
Dosage Form; Route of Administration: FOR SUSPENSION; INTRATRACHEAL
Strength: 12MG/VIAL;108MG/VIAL;8MG/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020044
Product Number: 001
Approval Date: Aug 2, 1990
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status:  Discontinued
Patent and Exclusivity Information
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