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VALTOCO (nda211635)- (5MG/SPRAY,7.5MG/SPRAY,10MG/SPRAY)

DIAZEPAM NEURELIS INC
5MG/SPRAY,7.5MG/SPRAY,10MG/SPRAY
Yes Yes
2029-Mar-27 Expired
None 2023-Jan-10
None No
VALTOCO is a benzodiazepine indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 6 years of age and older.
0 0 0
Total Other Developers 6
Drugs with Suitability No
5MG/SPRAY ** ** Up - -
7.5MG/SPRAY ** ** Up - -
10MG/SPRAY ** ** Up - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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