Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208692

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CABOMETYX (CABOZANTINIB S-MALATE)
EQ 20MG BASE
Marketing Status: Prescription

Active Ingredient: CABOZANTINIB S-MALATE
Proprietary Name: CABOMETYX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 20MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208692
Product Number: 001
Approval Date: Apr 25, 2016
Applicant Holder Full Name: EXELIXIS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CABOMETYX (CABOZANTINIB S-MALATE)
EQ 40MG BASE
Marketing Status: Prescription

Active Ingredient: CABOZANTINIB S-MALATE
Proprietary Name: CABOMETYX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 40MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208692
Product Number: 002
Approval Date: Apr 25, 2016
Applicant Holder Full Name: EXELIXIS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CABOMETYX (CABOZANTINIB S-MALATE)
EQ 60MG BASE
Marketing Status: Prescription

Active Ingredient: CABOZANTINIB S-MALATE
Proprietary Name: CABOMETYX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 60MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208692
Product Number: 003
Approval Date: Apr 25, 2016
Applicant Holder Full Name: EXELIXIS INC
Marketing Status:  Prescription
Patent and Exclusivity Information