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HETLIOZ (nda205677)- (20MG)

TASIMELTEON VANDA PHARMS INC
20MG
Yes No
2041-Feb-21 2019-Jan-31
2021-Jan-31 None
None No
HETLIOZ is a melatonin receptor agonist. HETLIOZ capsules are indicated for the treatment of: • Non-24-Hour Sleep-Wake Disorder (Non-24) in adults • Nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older.
3 0 3
Total Other Developers 2
Drugs with Suitability No
20MG ** ** - - 3
NDA Sales Available Total Generic Sales Available
Yes 3
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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