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Generated: October 21, 2018

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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 203388
Tradename:ERIVEDGE
Applicant:Genentech
Ingredient:vismodegib
Patents:2
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 203388
Generic Entry Date for 203388*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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
ERIVEDGE vismodegib CAPSULE;ORAL 203388 NDA Genentech, Inc. 50242-140 50242-140-86 1 BOTTLE, PLASTIC in 1 CARTON (50242-140-86) > 28 CAPSULE in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength150MG
Approval Date:Jan 30, 2012TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Nov 11, 2028Product Flag?YSubstance Flag?YDelist Request?
Patent:➤ Sign UpPatent Expiration:Dec 15, 2028Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF USING VISMODEGIB TO TREAT CANCER IN A MAMMAL

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