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LAMICTAL ODT (nda022251)- (25MG,50MG,100MG,200MG)

LAMOTRIGINE GLAXOSMITHKLINE LLC
25MG,50MG,100MG,200MG
Yes No
2029-Jan-04 Expired
None None
None No
LAMICTAL is indicated for: Epilepsy—adjunctive therapy in patients aged 2 years and older: • partial-onset seizures. • primary generalized tonic-clonic seizures. • generalized seizures of Lennox-Gastaut syndrome. Epilepsy—monotherapy in patients aged 16 years and older: Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug. Bipolar disorder: Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy.
5 0 5
Total Other Developers 7
Drugs with Suitability No
25MG ** ** - 4 -
50MG ** ** Up 4 -
100MG ** ** Up - 4
200MG ** ** Up 4 -
NDA Sales Available Total Generic Sales Available
Yes 4
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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