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Last Updated: April 19, 2024

Details for New Drug Application (NDA): 020044

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NDA 020044 describes EXOSURF NEONATAL, which is a drug marketed by Glaxosmithkline and is included in one NDA. Additional details are available on the EXOSURF NEONATAL profile page.

The generic ingredient in EXOSURF NEONATAL is cetyl alcohol; colfosceril palmitate; tyloxapol. There are ninety-one drug master file entries for this compound. Additional details are available on the cetyl alcohol; colfosceril palmitate; tyloxapol profile page.

Summary for 020044

Tradename:	EXOSURF NEONATAL
Applicant:	Glaxosmithkline
Ingredient:	cetyl alcohol; colfosceril palmitate; tyloxapol
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SUSPENSION;INTRATRACHEAL			Strength	12MG/VIAL;108MG/VIAL;8MG/VIAL
Approval Date:	Aug 2, 1990	TE:		RLD:	No

Expired US Patents for NDA 020044

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	EXOSURF NEONATAL	cetyl alcohol; colfosceril palmitate; tyloxapol	FOR SUSPENSION;INTRATRACHEAL	020044-001	Aug 2, 1990	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline	EXOSURF NEONATAL	cetyl alcohol; colfosceril palmitate; tyloxapol	FOR SUSPENSION;INTRATRACHEAL	020044-001	Aug 2, 1990	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline	EXOSURF NEONATAL	cetyl alcohol; colfosceril palmitate; tyloxapol	FOR SUSPENSION;INTRATRACHEAL	020044-001	Aug 2, 1990	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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