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Details for New Drug Application (NDA): 022527

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NDA 022527 describes GILENYA, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the GILENYA profile page.

The generic ingredient in GILENYA is fingolimod. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fingolimod profile page.

Summary for NDA: 022527


Pharmacology for NDA: 022527

Suppliers and Packaging for NDA: 022527

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE;ORAL 022527 NDA Novartis Pharmaceuticals Corporation 0078-0607 0078-0607-15 30 CAPSULE in 1 BOTTLE (0078-0607-15)
CAPSULE;ORAL 022527 NDA Novartis Pharmaceuticals Corporation 0078-0607 0078-0607-51 28 CAPSULE in 1 CARTON (0078-0607-51)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.5MG
Approval Date:Sep 21, 2010TE:RLD:Yes
Patent:8,324,283Patent Expiration:Mar 29, 2026Product Flag?Substance Flag?Delist Request?
Regulatory Exclusivity Expiration:Sep 21, 2015
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:5,604,229Patent Expiration:Feb 18, 2019Product Flag?Substance Flag?YDelist Request?

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