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Details for New Drug Application (NDA): 205053

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NDA 205053 describes NOXAFIL, which is a drug marketed by Schering and Merck Sharp Dohme and is included in three NDAs. It is available from one supplier. 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 eleven 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 NDA: 205053

Tradename:
NOXAFIL
Applicant:
Merck Sharp Dohme
Ingredient:
posaconazole
Patents:1
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Pharmacology for NDA: 205053

Ingredient-typeAzoles

Suppliers and Packaging for NDA: 205053

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NOXAFIL
posaconazole
TABLET, DELAYED RELEASE;ORAL 205053 NDA Merck Sharp & Dohme Corp. 0085-4324 0085-4324-02 60 TABLET, COATED in 1 BOTTLE (0085-4324-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength100MG
Approval Date:Nov 25, 2013TE:RLD:Yes
Patent:5,661,151Patent Expiration:Jul 19, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS

Expired Orange Book Patents for NDA: 205053

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme
NOXAFIL
posaconazole
TABLET, DELAYED RELEASE;ORAL205053-001Nov 25, 20135,703,079► subscribe
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