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SAPHRIS (nda022117)- (EQ 5MG BASE,EQ 10MG BASE,EQ 2.5MG BASE)

ASENAPINE MALEATE ALLERGAN
EQ 5MG BASE,EQ 10MG BASE,EQ 2.5MG BASE
Yes No
2026-Oct-06 2014-Aug-13
None None
None No
SAPHRIS is an atypical antipsychotic indicated for: • Schizophrenia in adults • Bipolar I disorder o Acute monotherapy treatment of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age o Adjunctive treatment to lithium or valproate in adults o Maintenance monotherapy treatment in adults.
3 0 3
Total Other Developers 3
Drugs with Suitability No
EQ 5MG BASE ** ** Up - 3
EQ 10MG BASE ** ** Up - 3
EQ 2.5MG BASE ** ** - - 2
NDA Sales Available Total Generic Sales Available
Yes 3
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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