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LYBALVI (nda213378)- (5MG;EQ 10MG BASE,10MG;EQ 10MG BASE,15MG;EQ 10MG BASE,20MG;EQ 10MG BASE)

OLANZAPINE; SAMIDORPHAN L-MALATE ALKERMES INC
5MG;EQ 10MG BASE,10MG;EQ 10MG BASE,15MG;EQ 10MG BASE,20MG;EQ 10MG BASE
No No
2041-Nov-12 2026-May-28
None None
None No
LYBALVI is a combination of olanzapine, an atypical antipsychotic, and samidorphan, an opioid antagonist, indicated for the treatment of: • Schizophrenia in adults • Bipolar I disorder in adults o Acute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate o Maintenance monotherapy treatment
0 0 0
Total Other Developers 1
Drugs with Suitability No
5MG;EQ 10MG BASE ** ** Up - -
10MG;EQ 10MG BASE ** ** Up - -
15MG;EQ 10MG BASE ** ** Up - -
20MG;EQ 10MG BASE ** ** Up - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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