Details for New Drug Application (NDA): 205596

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NDA 205596 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-eight suppliers are listed for this compound. Additional details are available on the posaconazole profile page.

Summary for 205596

Tradename:	NOXAFIL
Applicant:	Merck Sharp Dohme
Ingredient:	posaconazole
Patents:	6

Pharmacology for NDA: 205596

Suppliers and Packaging for NDA: 205596

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NOXAFIL	posaconazole	SOLUTION;INTRAVENOUS	205596	NDA	Merck Sharp & Dohme LLC	0085-4331	0085-4331-01	1 VIAL, GLASS in 1 CARTON (0085-4331-01) / 16.7 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	300MG/16.7ML (18MG/ML)
Approval Date:	Mar 13, 2014	TE:	AP	RLD:	Yes
Regulatory Exclusivity Expiration:	Jun 17, 2028
Regulatory Exclusivity Use:	FOR THE TREATMENT OF INVASIVE ASPERGILLOSIS IN ADULTS AND PEDIATRIC PATIENTS 13 YEARS OF AGE AND OLDER
Regulatory Exclusivity Expiration:	Jun 17, 2024
Regulatory Exclusivity Use:	FOR THE TREATMENT OF INVASIVE ASPERGILLOSIS IN PATIENTS 13 YEARS OF AGE AND OLDER
Regulatory Exclusivity Expiration:	May 31, 2024
Regulatory Exclusivity Use:	NEW PATIENT POPULATION

Expired US Patents for NDA 205596

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	NOXAFIL	posaconazole	SOLUTION;INTRAVENOUS	205596-001	Mar 13, 2014	⤷ Sign Up	⤷ Sign Up
Merck Sharp Dohme	NOXAFIL	posaconazole	SOLUTION;INTRAVENOUS	205596-001	Mar 13, 2014	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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