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Cerilliant
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Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205596

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NDA 205596 describes NOXAFIL, which is a drug marketed by Merck Sharp Dohme and Schering and is included in three NDAs. It is available from one supplier. There are eight 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 seventeen drug master file entries for this compound. One supplier is 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
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Pharmacology for NDA: 205596
Ingredient-typeAzoles
Suppliers and Packaging for NDA: 205596
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NOXAFIL posaconazole SOLUTION;IV (INFUSION) 205596 NDA Merck Sharp & Dohme Corp. 0085-4331 N 0085-4331-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength300MG/16.7ML (18MG/ML)
Approval Date:Mar 13, 2014TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jul 19, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS
Patent:➤ Sign UpPatent Expiration:Mar 13, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Jul 4, 2031Product Flag?YSubstance Flag?Delist Request?
Patented Use:PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS

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