Lupin receives USFDA approval for Chlorpromazine Hydrochloride tablets

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

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

drug approvalDrugsLupinUSFDA
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