Enforcement Report - Week of September 13, 2023
Caplin's Generic Cisatracurium Besylate Receives Receives Approval in the U.S.
Caplin's Generic Ketorolac Tromethamine Receives Receives Approval in the U.S.
Caplin's Generic Thiamine Hydrochloride Receives Approval in the U.S.
Caplin's Generic Carboprost Tromethamine Receives Approval in the U.S.
Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Limited, has been granted final approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application(ANDA) labetalol hydrochloride injection USP, 100 mg/20 mL (5 mg/mL) and 200mg/40 mL (5 mg/mL) multiple-dose vials, a generic therapeutic equivalent version of Trandate injection, of Sebela Ireland Limited.
Caplin's Generic Labetalol Hydrochloride Receives Approval in the US