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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 213969

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ZOKINVY (LONAFARNIB)
50MG
Marketing Status: Prescription
Active Ingredient: LONAFARNIB
Proprietary Name: ZOKINVY
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N213969
Product Number: 001
Approval Date: Nov 20, 2020
Applicant Holder Full Name: SENTYNL THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ZOKINVY (LONAFARNIB)
75MG
Marketing Status: Prescription
Active Ingredient: LONAFARNIB
Proprietary Name: ZOKINVY
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 75MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N213969
Product Number: 002
Approval Date: Nov 20, 2020
Applicant Holder Full Name: SENTYNL THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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