Lupin receives approval from USFDA for Chlorpromazine Hydrochloride Tablets USP
Drug Approval

Lupin receives approval from USFDA for Chlorpromazine Hydrochloride Tablets USP

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

  • By IPP Bureau | July 14, 2023

Lupin announced that its wholly-owned subsidiary, Lupin Inc., based in Somerset, New Jersey, 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. 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. (IQVIA MAT Mar 2023).

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