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SIRTURO (nda204384)- (EQ 100MG BASE,EQ 20MG BASE)

BEDAQUILINE FUMARATE JANSSEN THERAP
EQ 100MG BASE,EQ 20MG BASE
No No
2029-Mar-19 2017-Dec-28
2019-Dec-28 None
None No
SIRTURO is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in adult and pediatric patients (5 years and older and weighing at least 15 kg) with pulmonary multi-drug resistant tuberculosis (MDR-TB). Reserve SIRTURO for use when an effective treatment regimen cannot otherwise be provided.
0 0 0
Total Other Developers 2
Drugs with Suitability No
EQ 100MG BASE ** ** - - -
EQ 20MG BASE ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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Brand Name Generic Name Strength Dosage Route of Administration Innovator ParaIV

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