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news.Upsher-Smith Laboratories (Upsher-Smith) announced that it has received US Food and Drug Administration (FDA) approval of an abbreviated new drug application (ANDA) for Memantine Hydrochloride Tablets in 5mg and 10mg strengths.
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Memantine Hydrochloride Tablets are equivalent to the branded product, Namenda, which is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.
"Approximately 5.3 million Americans suffer from Alzheimer’s disease," said Rusty Field, President of Upsher-Smith. "With the FDA approval of Upsher-Smith’s generic Memantine Hydrochloride Tablets, it is our hope to increase access to a cost-effective alternative to Namenda for those patients experiencing moderate to severe dementia of the Alzheimer’s type."
The NDC number for Memantine Hydrochloride Tablets 5mg is 0832-1112-60. The NDC number for Memantine Hydrochloride Tablets 10mg is 0832-1113-60. For questions about ordering Memantine Hydrochloride Tablets, please call Upsher-Smith at 1-800-654-2299.
Memantine Hydrochloride Tablets are a prescription medicine used for the treatment of moderate to severe dementia in people with Alzheimer’s disease. Memantine Hydrochloride Tablets belongs to a class of medicines called NMDA (N-methyl-D-aspartate) inhibitors.
It is not known if Memantine Hydrochloride Tablets are safe and effective in children.