Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 202429

ZELBORAF (VEMURAFENIB)
240MG Marketing Status: Prescription

Active Ingredient: VEMURAFENIB
Proprietary Name: ZELBORAF
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 240MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N202429
Product Number: 001
Approval Date: Aug 17, 2011
Applicant Holder Full Name: HOFFMANN LA ROCHE INC
Marketing Status:  Prescription
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