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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 022003

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NDA 022003 describes NOXAFIL, which is a drug marketed by Merck Sharp Dohme, Schering, and Msd Merck Co, and is included in four NDAs. It is available from three suppliers. There are six patents protecting this drug and three Paragraph IV challenges. Additional details are available on the NOXAFIL profile page.

The generic ingredient in NOXAFIL is posaconazole. There are twenty-one drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the posaconazole profile page.

Summary for 022003

Tradename:	NOXAFIL
Applicant:	Schering
Ingredient:	posaconazole
Patents:	0

Pharmacology for NDA: 022003

Suppliers and Packaging for NDA: 022003

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NOXAFIL	posaconazole	SUSPENSION;ORAL	022003	NDA	Merck Sharp & Dohme LLC	0085-1328	0085-1328-01	1 BOTTLE, GLASS in 1 CARTON (0085-1328-01) / 105 mL in 1 BOTTLE, GLASS
NOXAFIL	posaconazole	SUSPENSION;ORAL	022003	NDA AUTHORIZED GENERIC	ENDO USA, Inc.	0254-1016	0254-1016-36	1 BOTTLE, GLASS in 1 CARTON (0254-1016-36) / 105 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	40MG/ML
Approval Date:	Sep 15, 2006	TE:	AB	RLD:	Yes

Expired US Patents for NDA 022003

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	NOXAFIL	posaconazole	SUSPENSION;ORAL	022003-001	Sep 15, 2006	5,661,151	⤷ Get Started Free
Schering	NOXAFIL	posaconazole	SUSPENSION;ORAL	022003-001	Sep 15, 2006	8,263,600	⤷ Get Started Free
Schering	NOXAFIL	posaconazole	SUSPENSION;ORAL	022003-001	Sep 15, 2006	6,958,337	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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