Glenmark gets USFDA nod for generic version of Thorazine Tablets
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Mumbai: Pharma major, Glenmark Pharmaceuticals Limited, today announced that the company has received final approval by the United States Food & Drug Administration (USFDA) for Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg.
The product is the generic version of Thorazine Tablets, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg, of GlaxoSmithKline.
Glenmark has been granted a competitive generic therapy (CGT) designation for Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg, therefore, with this approval, Glenmark is the first approved applicant for such competitive generic therapy and is eligible for 180 days of CGT exclusivity upon commercial marketing.
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