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QUDEXY XR (nda205122)- (25MG,50MG,100MG,150MG,200MG)

TOPIRAMATE UPSHER SMITH LABS
25MG,50MG,100MG,150MG,200MG
Yes Yes
2033-Mar-19 Expired
None None
None No
QUDEXY XR is indicated for: • Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older; adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut Syndrome in patients 2 years of age and older • Preventive treatment of migraine in patients 12 years of age and older
3 0 2
Total Other Developers 10
Drugs with Suitability No
25MG ** ** - - 2
50MG ** ** - - 2
100MG ** ** - - 2
150MG ** ** - - 2
200MG ** ** - - 2
NDA Sales Available Total Generic Sales Available
Yes 2
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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Brand Name Generic Name Strength Dosage Route of Administration Innovator ParaIV

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