Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 215358

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SCEMBLIX (ASCIMINIB HYDROCHLORIDE)
EQ 20MG BASE
Marketing Status: Prescription

Active Ingredient: ASCIMINIB HYDROCHLORIDE
Proprietary Name: SCEMBLIX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 20MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N215358
Product Number: 001
Approval Date: Oct 29, 2021
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

SCEMBLIX (ASCIMINIB HYDROCHLORIDE)
EQ 40MG BASE
Marketing Status: Prescription

Active Ingredient: ASCIMINIB HYDROCHLORIDE
Proprietary Name: SCEMBLIX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 40MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215358
Product Number: 002
Approval Date: Oct 29, 2021
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

SCEMBLIX (ASCIMINIB HYDROCHLORIDE)
EQ 100MG BASE
Marketing Status: Prescription

Active Ingredient: ASCIMINIB HYDROCHLORIDE
Proprietary Name: SCEMBLIX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N215358
Product Number: 003
Approval Date: Apr 18, 2024
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information