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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 022003


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NDA 022003 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-six suppliers are listed for this compound. Additional details are available on the posaconazole profile page.
Summary for 022003
Tradename:NOXAFIL
Applicant:Schering
Ingredient:posaconazole
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 022003
Suppliers and Packaging for NDA: 022003
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NOXAFIL posaconazole SUSPENSION;ORAL 022003 NDA Merck Sharp & Dohme LLC 0085-1328 0085-1328-01 1 BOTTLE, GLASS in 1 CARTON (0085-1328-01) / 105 mL in 1 BOTTLE, GLASS
NOXAFIL posaconazole SUSPENSION;ORAL 022003 NDA AUTHORIZED GENERIC Par Pharmaceutical Inc. 0254-1016 0254-1016-36 1 BOTTLE, GLASS in 1 CARTON (0254-1016-36) / 105 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength40MG/ML
Approval Date:Sep 15, 2006TE:ABRLD:Yes

Expired US Patents for NDA 022003

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Schering NOXAFIL posaconazole SUSPENSION;ORAL 022003-001 Sep 15, 2006 ⤷  Try a Trial ⤷  Try a Trial
Schering NOXAFIL posaconazole SUSPENSION;ORAL 022003-001 Sep 15, 2006 ⤷  Try a Trial ⤷  Try a Trial
Schering NOXAFIL posaconazole SUSPENSION;ORAL 022003-001 Sep 15, 2006 ⤷  Try a Trial ⤷  Try a Trial
Schering NOXAFIL posaconazole SUSPENSION;ORAL 022003-001 Sep 15, 2006 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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