U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 213591

Expand all

TABRECTA (CAPMATINIB HYDROCHLORIDE)
EQ 150MG BASE
Marketing Status: Prescription
Active Ingredient: CAPMATINIB HYDROCHLORIDE
Proprietary Name: TABRECTA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 150MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N213591
Product Number: 001
Approval Date: May 6, 2020
Applicant Holder Full Name: NOVARTIS PHARMACEUTICAL CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
TABRECTA (CAPMATINIB HYDROCHLORIDE)
EQ 200MG BASE
Marketing Status: Prescription
Active Ingredient: CAPMATINIB HYDROCHLORIDE
Proprietary Name: TABRECTA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 200MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N213591
Product Number: 002
Approval Date: May 6, 2020
Applicant Holder Full Name: NOVARTIS PHARMACEUTICAL CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top