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Details for New Drug Application (NDA): 202429

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NDA 202429 describes ZELBORAF, which is a drug marketed by Hoffmann La Roche and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the ZELBORAF profile page.

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

Summary for NDA: 202429

Tradename:
ZELBORAF
Applicant:
Hoffmann La Roche
Ingredient:
vemurafenib
Patents:6
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 202429

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZELBORAF
vemurafenib
TABLET;ORAL 202429 NDA Genentech, Inc. 50242-090 50242-090-01 1 BOTTLE, PLASTIC in 1 CARTON (50242-090-01) > 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
ZELBORAF
vemurafenib
TABLET;ORAL 202429 NDA Genentech, Inc. 50242-090 50242-090-02 1 BOTTLE, PLASTIC in 1 CARTON (50242-090-02) > 112 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength240MG
Approval Date:Aug 17, 2011TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 31, 2019
Regulatory Exclusivity Use:
Patent:7,504,509Patent Expiration:Oct 22, 2026Product Flag?YSubstance Flag?YDelist Request?
Patent:7,863,288Patent Expiration:Jun 20, 2029Product Flag?YSubstance Flag?YDelist Request?


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