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news.Aurobindo Pharma has received tentative approval for its abbreviated new drug application (ANDA) from the US Food & Drug Administration (FDA) for Donepezil Hydrochloride tablets 5mg and 10mg.
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Donepezil Hydrochloride tablets are indicated for the treatment of mild, moderate, and severe dementia of the Alzheimer’s type and fall under the central nervous system (CNS) therapeutic segment.
Aurobindo Pharma‘s Donepezil Hydrochloride tablets 5mg and 10mg are generic equivalent to Eisai Medical Research’s Aricept tablets 5mg and 10mg.
In total, the company has 136 ANDA approvals from the FDA.