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PRETOMANID (nda212862)- (200MG)

PRETOMANID MYLAN IRELAND LTD
200MG
No No
Expired 2024-Aug-14
None None
2029-Aug-14 No
Limited Population: Pretomanid Tablet is an antimycobacterial indicated, as part of a combination regimen with bedaquiline and linezolid for the treatment of adults with pulmonary extensively drug resistant (XDR), treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB). Approval of this indication is based on limited clinical safety and efficacy data. This drug is indicated for use in a limited and specific population of patients.
0 0 0
Total Other Developers 4
Drugs with Suitability No
200MG ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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