Enforcement Report - Week of August 24, 2022
Unichem Lab's Generic Labetalol Hydrochloride 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
Rubicon`s Generic Labetalol HCl Receives Approval In the US
Epic Pharma Llc's Generic Labetalol Hydrochloride Receives Approval In US
Cadila Pharms Generic Labetalol Hydrochloride Receives Approval in US
Enforcement Report - Week of May 1, 2019
Enforcement Report for Week of February 20, 2019
Invatech Pharma's Generic Labetalol Hydrochloride Receives Approval in US