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Details for New Drug Application (NDA): 203388

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NDA 203388 describes ERIVEDGE, which is a drug marketed by Genentech and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the ERIVEDGE profile page.

The generic ingredient in ERIVEDGE is vismodegib. One supplier is listed for this compound. Additional details are available on the vismodegib profile page.

Summary for NDA: 203388

Tradename:
ERIVEDGE
Applicant:
Genentech
Ingredient:
vismodegib
Patents:2
Formulation / Manufacturing:see details

Pharmacology for NDA: 203388

Suppliers and Packaging for NDA: 203388

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ERIVEDGE
vismodegib
CAPSULE;ORAL 203388 NDA Genentech, Inc. 50242-140 50242-140-01 1 BOTTLE, PLASTIC in 1 CARTON (50242-140-01) > 28 CAPSULE in 1 BOTTLE, PLASTIC

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength150MG
Approval Date:Jan 30, 2012TE:RLD:Yes
Patent:7,888,364Patent Expiration:Nov 11, 2028Product Flag?YSubstance Flag?YDelist Request?
Patent:9,278,961Patent Expiration:Dec 15, 2028Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF USING VISMODEGIB TO TREAT CANCER IN A MAMMAL
Regulatory Exclusivity Expiration:Jan 30, 2017
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY


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