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Last Updated: July 8, 2020

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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 Merck Sharp Dohme and Schering and is included in three NDAs. It is available from two suppliers. There are seven 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. Four suppliers are listed for this compound. Additional details are available on the posaconazole profile page.
Summary for 205053
Tradename:NOXAFIL
Applicant:Merck Sharp Dohme
Ingredient:posaconazole
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 205053
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)
NOXAFIL posaconazole TABLET, DELAYED RELEASE;ORAL 205053 NDA AUTHORIZED GENERIC Par Pharmaceutical Inc. 0254-2045 0254-2045-02 60 TABLET, COATED in 1 BOTTLE (0254-2045-02)
Paragraph IV (Patent) Challenges for 205053
Tradename Dosage Ingredient NDA Submissiondate
NOXAFIL TABLET, DELAYED RELEASE;ORAL posaconazole 205053 2014-06-16

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength100MG
Approval Date:Nov 25, 2013TE:ABRLD:Yes

Expired US Patents for NDA 205053

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme NOXAFIL posaconazole TABLET, DELAYED RELEASE;ORAL 205053-001 Nov 25, 2013   Start Trial   Start Trial
Merck Sharp Dohme NOXAFIL posaconazole TABLET, DELAYED RELEASE;ORAL 205053-001 Nov 25, 2013   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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