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LAMICTAL CD (nda020764)- (2MG,5MG,25MG,100MG)

LAMOTRIGINE GLAXOSMITHKLINE LLC
2MG,5MG,25MG,100MG
Yes No
2012-Jul-29 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.
7 0 6
Total Other Developers None
Drugs with Suitability Yes
2MG ** ** - - -
5MG ** ** - 3 -
25MG ** ** Up - 4
100MG ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 6
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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