Unichem receives ANDA approval for quetiapine extended-release tablets

Unichem receives ANDA approval for quetiapine extended-release tablets

By: IPP Bureau

Last updated : August 16, 2022 10:56 pm



Quetiapine Extended-Release Tablets are indicated for the treatment of Schizophrenia, Bipolar disorder and adjunctive treatment of Major Depressive Disorder (MDD)


Unichem Laboratories Limited has received ANDA approval for its Quetiapine Extended-Release Tablets USP, 50 mg, 150 mg, 200 mg, 300 mg, and 400 mg from the United States Food and Drug Administration (USFDA) to market a generic version of SEROQUEL XR® (Quetiapine) Tablet, Extended Release, 50 mg, 150 mg, 200 mg, 300 mg, and 400 mg of AstraZeneca Pharmaceuticals LP.

Quetiapine Extended-Release Tablets are indicated for the treatment of Schizophrenia, Bipolar disorder and adjunctive treatment of Major Depressive Disorder (MDD). The product will be commercialized from Unichem's Goa Plant.

Unichem Laboratories Limited

First Published : August 16, 2022 12:00 am