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Details for New Drug Application (NDA): 203985

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NDA 203985 describes AFINITOR DISPERZ, which is a drug marketed by Novartis Pharm and is included in one NDA. It is available from one supplier. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the AFINITOR DISPERZ profile page.

The generic ingredient in AFINITOR DISPERZ is everolimus. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the everolimus profile page.

Summary for NDA: 203985

Tradename:
AFINITOR DISPERZ
Applicant:
Novartis Pharm
Ingredient:
everolimus
Patents:5
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 203985

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AFINITOR DISPERZ
everolimus
TABLET, FOR SUSPENSION;ORAL 203985 NDA Novartis Pharmaceuticals Corporation 0078-0626 0078-0626-51 28 BLISTER PACK in 1 CARTON (0078-0626-51) > 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (0078-0626-61)
AFINITOR DISPERZ
everolimus
TABLET, FOR SUSPENSION;ORAL 203985 NDA Novartis Pharmaceuticals Corporation 0078-0627 0078-0627-51 28 BLISTER PACK in 1 CARTON (0078-0627-51) > 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (0078-0627-61)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, FOR SUSPENSION;ORALStrength2MG
Approval Date:Aug 29, 2012TE:RLD:Yes
Patent:5,665,772*PEDPatent Expiration:Mar 9, 2020Product Flag?Substance Flag?Delist Request?Y
Patent:6,004,973*PEDPatent Expiration:Jan 12, 2017Product Flag?Substance Flag?Delist Request?Y
Patent:7,297,703*PEDPatent Expiration:Jun 6, 2020Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 203985

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharm
AFINITOR DISPERZ
everolimus
TABLET, FOR SUSPENSION;ORAL203985-003Aug 29, 20126,004,973*PED► subscribe
Novartis Pharm
AFINITOR DISPERZ
everolimus
TABLET, FOR SUSPENSION;ORAL203985-002Aug 29, 20126,004,973*PED► subscribe
Novartis Pharm
AFINITOR DISPERZ
everolimus
TABLET, FOR SUSPENSION;ORAL203985-001Aug 29, 20126,004,973*PED► subscribe
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