Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 204384

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SIRTURO (BEDAQUILINE FUMARATE)
EQ 20MG BASE
Marketing Status: Prescription
Active Ingredient: BEDAQUILINE FUMARATE
Proprietary Name: SIRTURO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 20MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204384
Product Number: 002
Approval Date: May 27, 2020
Applicant Holder Full Name: JANSSEN THERAPEUTICS DIV JANSSEN PRODUCTS LP
Marketing Status:  Prescription
Patent and Exclusivity Information
SIRTURO (BEDAQUILINE FUMARATE)
EQ 100MG BASE
Marketing Status: Prescription
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

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