Active Ingredient: BEDAQUILINE FUMARATE
Proprietary Name: SIRTURO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N204384
Product Number: 001
Approval Date: Dec 28, 2012
Applicant Holder Full Name: JANSSEN THERAPEUTICS DIV JANSSEN PRODUCTS LP
Marketing Status:
Prescription
Patent and Exclusivity Information