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Generated: January 22, 2019

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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 nine 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. 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:7
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 205596
Generic Entry Date for 205596*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;IV (INFUSION)

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 Corp. 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:RXDosage:SOLUTION;INTRAVENOUSStrength300MG/16.7ML (18MG/ML)
Approval Date:Mar 13, 2014TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Mar 13, 2029Product Flag?YSubstance Flag?Delist Request?
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?

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