USFDA gives approval for Prochlorperazine Maleate Tablets USP

Glenmark’s Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg, will be distributed in the US by Glenmark Pharmaceuticals.

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USFDA Drug product Approval
USFDA Approval

Last Updated on December 24, 2023 by The Health Master

Glenmark Pharmaceuticals has received final approval by the United States Food & Drug Administration (USFDA) for Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg, the generic version of Compazine Tablets, 5 mg and 10 mg, of GlaxoSmithKline.

Glenmark’s Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg, will be distributed in the US by Glenmark Pharmaceuticals.

According to IQVIA sales data for the 12-month period ending January 2023, the Compazine Tablets, 5 mg and 10 mg market achieved annual sales of approximately $26.9 million*.

Glenmark’s current portfolio consists of 182 products authorised for distribution in the US marketplace and 46 ANDAs pending approval with the USFDA.

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