Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 218171

Expand all

ENSACOVE (ENSARTINIB HYDROCHLORIDE)
EQ 25MG BASE
Marketing Status: Prescription

Active Ingredient: ENSARTINIB HYDROCHLORIDE
Proprietary Name: ENSACOVE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 25MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N218171
Product Number: 001
Approval Date: Dec 18, 2024
Applicant Holder Full Name: XCOVERY HOLDINGS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ENSACOVE (ENSARTINIB HYDROCHLORIDE)
EQ 100MG BASE
Marketing Status: Prescription

Active Ingredient: ENSARTINIB HYDROCHLORIDE
Proprietary Name: ENSACOVE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N218171
Product Number: 002
Approval Date: Dec 18, 2024
Applicant Holder Full Name: XCOVERY HOLDINGS INC
Marketing Status:  Prescription
Patent and Exclusivity Information