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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 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: 205596

Tradename:
NOXAFIL
Applicant:
Merck Sharp Dohme
Ingredient:
posaconazole
Patents:4
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 0085-4331-01 1 VIAL, GLASS in 1 CARTON (0085-4331-01) > 16.7 mL in 1 VIAL, GLASS

Summary 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:8,410,077Patent Expiration:Mar 13, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:5,661,151Patent Expiration:Jul 19, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS
Patent:9,023,790Patent Expiration:Jul 4, 2031Product Flag?YSubstance Flag?Delist Request?
Patented Use:PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS

Expired Orange Book Patents for NDA: 205596

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme
NOXAFIL
posaconazole
SOLUTION;IV (INFUSION)205596-001Mar 13, 20145,703,079► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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