USFDA gives approval for Chlorpromazine HCL tablets

This product will be manufactured at Lupin’s Somerset facility in the U.S.

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USFDA Drug product Approval
USFDA Approval

Last Updated on December 24, 2023 by The Health Master

Lupin has announced that it has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg.

This drug approval is to market a generic equivalent to the reference listed drug (RLD), Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg of Upsher-Smith Laboratories, LLC.

This product will be manufactured at Lupin’s Somerset facility in the U.S.

Chlorpromazine Hydrochloride Tablets USP had an estimated annual sale of USD 45 million in the U.S.

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