Enforcement Report - Week of August 9, 2023
Enforcement Report for Week of June 28, 2023
Enforcement Report - Week of June 14, 2023
DUBLIN, June 12, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that its Par Sterile Products business has begun shipping PREVDUO™ (neostigmine methylsulfate and glycopyrrolate injection) pre-filled syringe, the first and only FDA-approved neostigmine–glycopyrrolate combination product in the U.S.
Enforcement Report - Week of March 8, 2023
Global pharma major Lupin Limited has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Glycopyrrolate Injection USP, a generic equivalent of Robinul Injection, 0.2 mg/mL of Hikma Pharmaceuticals USA Inc.
Enforcement Report - Week of January 4, 2023
Enforcement Report - Week of December 28, 2022
Aspen's Generic Glycopyrrolate Receives Approval in the U.S.
Alembic Pharmaceuticals Ltd on Tuesday said it has received final approval from the US health regulator for its generic version of Glycopyrrolate injection used as a pre-operative medication to inhibit salivary gland and respiratory secretions. The approval by the US Food & Drug Administration (USFDA) is for the Abbreviated New Drug Application (ANDA) for Glycopyrrolate injection. The approval is for strengths 0.2 mg/1 mL and 0.4 mg/2 mL (0.2 mg/mL) single-dose vials and 1 mg/5 mL (0.2 mg/mL) and 4 mg/20 mL (0.2 mg/mL) multiple-dose vials, according to a regulatory filing.