Aurobindo Pharma receives approvals

Our News BureauMumbai

Aurobindo Pharma has received final approvals from the US Food & Drug Administration (US FDA) to market quetiapine fumarate tablets 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 300 mg and 400 mg (ANDA 091388) quetiapine fumarate tablets 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 300 mg and 400 mg are the generic equivalent of AstraZeneca LP’s seroquel tablets 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 300 mg and 400 mg.

Quetiapine fumarate tablets are indicated for the treatment of serious psychotic disorders such as Schizophrenia and bipolar disorder and falls under the neurological (CNS) therapeutic category. The product has been approved out of unit III facility in Hyderabad. Aurobindo now has a total of 147 ANDA approvals (118 final approvals and 29 tentative approvals) from US FDA.

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