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The US health regulator USFDA has given its approval to Unichem Laboratories for its generic Quetiapine Fumarate tablets that are used in the treatment of schizophrenia and bipolar disorder.
Unichem Laboratories has said in a BSE filing that “The company has received Abbreviated New Drug Application (ANDA) approval from the United States Food and Drug Administration (USFDA) for Quetiapine Fumarate tablets.”
It further added that this approval is for the company’s tablets in the strength of 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, and 400 mg.
